Registration Dossier
Registration Dossier
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EC number: 617-560-2 | CAS number: 84377-83-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea pig topical sensitisation test
- GLP compliance:
- no
- Type of study:
- other: guinea pig topical sensitisation test
- Justification for non-LLNA method:
- Study was carried out before LLNA was considered a requirement. It is considered sufficient for the endpoint, so there was no need for an additional LLNA study, which would involve more animals.
Test material
- Reference substance name:
- 1-{[(6R,7R)-7-[(2Z)-2-({[1-(tert-butoxy)-2-methyl-1-oxopropan-2-yl]oxy}imino)-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium
- EC Number:
- 617-560-2
- Cas Number:
- 84377-83-3
- Molecular formula:
- C45H44O7S2.5/2(C3H7NO)
- IUPAC Name:
- 1-{[(6R,7R)-7-[(2Z)-2-({[1-(tert-butoxy)-2-methyl-1-oxopropan-2-yl]oxy}imino)-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium
- Reference substance name:
- N,N-dimethylformamide
- EC Number:
- 200-679-5
- EC Name:
- N,N-dimethylformamide
- Cas Number:
- 68-12-2
- Molecular formula:
- C3H7NO
- IUPAC Name:
- N,N-dimethylformamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Moisture content 0.16% w/w (Karl FIscher) as supplied to laboratory.
Batch Number: G309569
Constituent 1
additive 1
- Specific details on test material used for the study:
- Batch No: RJ1173
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Five male and five female guinea pigs, initially weighing 250-300 g.
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: epicutaneous, no other information mentioned
- Vehicle:
- other: saline:2-methoxyethanol:Tween 80 (45:45:10)
- Concentration / amount:
- not mentioned
- Day(s)/duration:
- not mentioned
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: epicutaneous, not specified
- Vehicle:
- other: saline:2-methoxyethanol:Tween 80 (45:45:10)
- Concentration / amount:
- Not specified
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5
- Positive control substance(s):
- yes
- Remarks:
- Benzyl penicillin
Results and discussion
- Positive control results:
- At 24 hours, only 2/9 animals treated with Benzyl Penicillin gave positive results. This increased to 5/9 animals at 48 hours. This is a low result for the positive control substance, as sensitisation usually occurs in >80% of the animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Not available
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Not available
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not available
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not available
- No. with + reactions:
- 5
- Total no. in group:
- 9
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Skin sensitising potential of 1132/4 DMF (CQ Intermediate) is low, but cannot be ignored.
Over 20% of the animals showed positive responses to the challenge after 48 hours, which is sufficient to classify the substance as a Skin Sensitiser Category 1, according to the criteria set for animal studies in section 3.4.2.2.4.1 of Annex I of the CLP Regulation. - Executive summary:
The skin sensitisation potential of 0/4 dihydrochloride dihydrate, 1132/4 DMF and 1132/4 bis hydrochloride was assessed in the guinea pig topical sensitisation test. The results indicate that repeated contact of the human skin with 0/4 dihydrochloride dihydrate might produce contact dermatitis. The contact allergenic potential of 1132/4 DMF although low, cannot be ignored, and that of 1132/4 bis hydrochloride, if any, is very low.
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