EFSA Compendium of Botanicals

Draft - work in progress

Safflower (as plant) // Carthamus tinctorius L.

Family:: Asteraceae
Approval state:: Approved
Number of articles retrieved:: 6395
Number of processed references:: 4

Compositions

#1: 4-hydroxyacetophenone in the plant #2: 4-hydroxybenzoic acid in the plant #3: 4-hydroxybenzaldehyde in the plant

Endpoint Studies

#1: teratogenic effects and reduction in embryo weight at the dose of 1.2 mg/kg/day in mice

Genotoxicity

#1: Mutagenicity activities at a concentration (0.78-25 mg/mL) in TA98 strains of Salmonella typhimurium #2: Mutagenicity (increased number of aberrant cells) in mice #3: Genotoxicity (increased number of MN/1000 PCEs) in mice

Composition #1: Li, Xiao-Feng., Hu, Xiao-Ru., Dai, Zhong., Zhang, Yan., Liang, Hong., Lin, Rui-Chao. Study on chemical constituents of Carthamus tinctorius .. zhong yao cai = zhongyaocai = journal of chinese medicinal materials, 2012, vol. 35, no. 10, p. 1616–9. .

Language:

English (en)
Plant part:

Live plants (as part-nature) (A0BA0)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

water
Substance:

4-Hydroxyacetophenone (RF-00002341-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Analytical method - additional description:

Sephadex, silica gel, resin columns, prep HPLC with spectral detection
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

4-hydroxyacetophenone in the plant

Composition #2: Li, Xiao-Feng., Hu, Xiao-Ru., Dai, Zhong., Zhang, Yan., Liang, Hong., Lin, Rui-Chao. Study on chemical constituents of Carthamus tinctorius .. zhong yao cai = zhongyaocai = journal of chinese medicinal materials, 2012, vol. 35, no. 10, p. 1616–9. .

Language:

English (en)
Plant part:

Live plants (as part-nature) (A0BA0)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

water
Substance:

4-Hydroxybenzoic acid (RF-00008325-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Analytical method - additional description:

Sephadex, silica gel, resin columns, prep HPLC with spectral detection
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

4-hydroxybenzoic acid in the plant

Composition #3: Li, Xiao-Feng., Hu, Xiao-Ru., Dai, Zhong., Zhang, Yan., Liang, Hong., Lin, Rui-Chao. Study on chemical constituents of Carthamus tinctorius .. zhong yao cai = zhongyaocai = journal of chinese medicinal materials, 2012, vol. 35, no. 10, p. 1616–9. .

Language:

English (en)
Plant part:

Live plants (as part-nature) (A0BA0)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

water
Substance:

4-Hydroxybenzaldehyde (RF-00001976-PAR)
Analytical method code:

High Performance Liquid Chromatography (HPLC)/Liquid Chromatography (LC) (F018A)
Analytical method - additional description:

Sephadex, silica gel, resin columns, prep HPLC with spectral detection
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Qualitative Value (Binary) (BIN)
Internal remarks:

4-hydroxybenzaldehyde in the plant

Endpoint study #1: Nobakht, M., Fattahi, M., Hoormand, M., Milanian, I., Rahbar, N., Mahmoudian, M. A study on the teratogenic and cytotoxic effects of safflower extract. journal of ethnopharmacology, 2000, vol. 73, no. 3, p. 453–459. DOI: 10.1016/S0378-8741(00)00324-X. [DOI link]

Study relevance:

Human health
Plant part:

Flower (as part-nature) (A067B)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

boiling water
Type of toxicological test:

reproduction toxicity (CHD009TT)
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Female
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Exposure duration:

8.0
Unit of exposure duration:

Day (G134A)
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

1.2-2
Critical effect:

REPRODUCTIVE (TOX05A)
Effect description:

Plant extract from dose of 1.2 mg/kg/day administered for 8 days displayed teratogenic effects and, in higher doses, an increase in embryo absorption was observed.
Effect or parameter linked to the endpoint:

reproduction (CHD014BE)
Internal remarks:

teratogenic effects and reduction in embryo weight at the dose of 1.2 mg/kg/day in mice

Genotox #1: Abudayyak, Mahmoud., Ozdemir Nath, Ebru., Ozhan, Gul. Toxic potentials of ten herbs commonly used for aphrodisiac effect in Turkey. turkish journal of medical sciences, 2015, vol. 45, no. 3, p. 496–506. DOI: 10.3906/sag-1401-153. [DOI link]

Study category:

Mutagenicity
Type of toxicological test:

bacterial reverse mutation assay (CHD028TT)
Method type:

in vitro
Tested organism:

Salmonella typhimurium (as organism) (A0CPZ)
Strain of test organism:

TA 98 (CHD029ST)
Sex:

No data
Exogenous metabolic activation applied:

without
Route of exposure:

OTHER (OECD0PL)
Control groups used:

yes
Endpoint measured:

gene mutation
Is genotoxic:

Positive
Remarks on genotox study:

water extract showed mutagenic activities at a concentration (0.78-25 mg/mL) in TA98 strains of Salmonella typhimurium without metabolic activation
Internal remarks:

Mutagenicity activities at a concentration (0.78-25 mg/mL) in TA98 strains of Salmonella typhimurium
Internal ID:

WOS:000356357800005

Genotox #2: YIN, XJ., LIU, DX., WANG, HC., ZHOU, Y. A STUDY ON THE MUTAGENICITY OF 102 RAW PHARMACEUTICALS USED IN CHINESE TRADITIONAL MEDICINE. mutation research, 1991, vol. 260, no. 1, p. 73–82. .

Study category:

Mutagenicity
Type of toxicological test:

chromosome aberration assay (CHD047TT)
Method type:

in vivo
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Male/Female
Route of exposure:

OTHER (OECD0PL)
Exposure duration for in vivo:

4.0
Unit of exposure duration:

Grams per kilogram body weight (G226A)
Number of organisms dosed:

10
Control groups used:

yes
Endpoint measured:

chromosome aberration
Is genotoxic:

Positive
Remarks on genotox study:

Dose increase number of aberrant cells at dose 0.5-4.0 gram/kilogram bw
Internal remarks:

Mutagenicity (increased number of aberrant cells) in mice
Internal ID:

WOS:A1991FK36700010

Genotox #3: YIN, XJ., LIU, DX., WANG, HC., ZHOU, Y. A STUDY ON THE MUTAGENICITY OF 102 RAW PHARMACEUTICALS USED IN CHINESE TRADITIONAL MEDICINE. mutation research, 1991, vol. 260, no. 1, p. 73–82. .

Study category:

Genotoxicity
Type of toxicological test:

Mammalian erythrocyte micronucleus test (CHD057TT)
Method type:

in vivo
Tested organism:

House mouse (as animal) (A0CNT)
Sex:

Male/Female
Route of exposure:

OTHER (OECD0PL)
Exposure duration for in vivo:

4.0
Unit of exposure duration:

Grams per kilogram body weight (G226A)
Number of organisms dosed:

10
Control groups used:

yes
Endpoint measured:

DNA damage and/or repair
Is genotoxic:

Positive
Remarks on genotox study:

Dose increase number of MN/1000 PCEs at dose 0.5-4.0 gram/kilogram bw
Internal remarks:

Genotoxicity (increased number of MN/1000 PCEs) in mice
Internal ID:

WOS:A1991FK36700010