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EC number: 435-990-7 | CAS number: 371921-34-5
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 22 to March 1, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a GPMT method was available
Test material
- Reference substance name:
- Yellow 981
- IUPAC Name:
- Yellow 981
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Remarks:
- Himalayan spotted: lbm: GOHI; SPF-quality guinea pigs
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- 20 %
- Day(s)/duration:
- day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- 50 %
- Day(s)/duration:
- day 8 / 48 h
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Concentration / amount:
- 10 %
- Day(s)/duration:
- day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 15 female animals (10 treatment + 5 negative control)
- Details on study design:
- - Day 1: 6 × 8 cm region clipped from scapular region, and three pairs of intradermal injections (0.1 ml per site) were given to each animal (1st pair: 1:1 (v/v) mixture of Freund's Complete Adjuvant (FCA) and physiological saline; 2nd pair: 20 % test item in bi-distilled water; 3rd pair: 20 % test item 50 % FCA).
- Day 8: same area was re-clipped and a 2 × 4 cm patch of filter paper saturated with 0.3 ml of test item (50 % test item in bi-distilled water) was placed over the injection sites. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape for 48 hours.
- Day 10: occlusive dressings were removed.
- Day 11: site assessed for erythema and oedema (24 h after removal).
- Day 12: site assessed for erythema and oedema (48 h after removal).
- Day 22: 3 × 3 cm filter paper saturated with 10 % test item in bi-distilled water was applied to the left, clipped flank of each animal for 24 h, and covered in the same way as stated above; additionally, the right flank of each animal was treated with bi-distilled water in the same way as the left.
- Day 23: dressings were removed 24 hours after application.
- Day 24: flanks were depilated (21 h after removal) and scored for erythema and oedema (24 h after removal).
- Day 25: flanks were scored for erythema and oedema (48 h after removal). - Challenge controls:
- - Intradermal induction: water in place of test item
- Epidermal induction: water in place of test item
- Epidermal challenge: same as treatment group - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole (intradermal induction: 5 %; epidermal induction: 15 %; challenge: 1 %)
Results and discussion
- Positive control results:
- Sensitisation rate after 24 and 48 hours: 100 %
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 % 2-mercaptobenzothiazole
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 % 2-mercaptobenzothiazole
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Sensitisation rate: 0 %, thus, the substance is not a skin sensitiser.
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