Registration Dossier
Registration Dossier
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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
Endpoint summary
Administrative data
Description of key information
Not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 22nd to May 23rd, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17th, 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A Guinea Pig Maximization Test was available
- Specific details on test material used for the study:
- Stable in water, polyethylene glicol (PEG 400), Freund’s Complete Adjuvant and physiological saline for 48 hours.
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 8 / 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 22 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in pretest: 6
Number of animals in test group of main study: 20
Number of animals in negative control group of main study: 10 - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
- Positive control results:
- The non-irritating test article concentration used for the challenge application of the positive control was 15 % in mineral oil. 95 % of the animals were observed with positive skin reactions after treatment with a non-irritating concentration of 15% in mineral oil. No skin reaction were observed in the negative control group. According to the rating of allergenicity by Magnusson and Kligman, the positive control tested under the test conditions is considered as an extreme sensitizer.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 18
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 18
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: not classified within the CLP Regulation (EC1272/2008)
- Conclusions:
- The test substance is not sensitising under the condition of the test.
- Executive summary:
In order to assess the cutaneous allergenic potential of the test substance, the Maximization-test in accordance with OECD Guideline No. 406 was carried out in 30 (20 test and 10 control) albino guinea pigs.
According to the procedures used in this experiment, no differences between the test group and the vehicle-treated controls where evident after epidermal challenge application of the test substance. The test item is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
According to CLP Regulation n. 1272/2008, a substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test (see specific criteria in section 3.4.2.2.4.1).
Sub-category 1A: Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.
No toxic symptoms were evident in the guinea pigs of either the control and test group.
Based on the above considerations, the substance is considered to be non-sensitiser and thus a classification for skin sensitisation as per the CLP Regulation (EC) No.1272/2008 is not applied.
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