Registration Dossier
Registration Dossier
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EC number: 272-056-6 | CAS number: 68672-66-2
Endpoint summary
Administrative data
Description of key information
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:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- 5 animals per group were used instead of 15 and 10% reaction level was achieved instead of the required 15% however the concentration used was only 4%w/v. There was limited information on the test procedure or solvent control results
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea pig topical sensitisation test Beuhler study
- 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.
- 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. 1 male and 1 female per group
- Route:
- other: epicutaneous, no other information mentioned
- Vehicle:
- other: 95% ethanol:methlyellosolve:tween 80 (45:45:10 parts in volume)
- Remarks:
- substance was insoluble and applied as a suspension in 95% ethanol:methlyellosolve:tween 80
- Concentration / amount:
- 4% w/v
- Day(s)/duration:
- five occasions at 2 day intervals
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: topical application
- Vehicle:
- other: 95% ethanol:methlyellosolve:tween 80 (45:45:10 parts in volume)
- Concentration / amount:
- 4% solution
- Day(s)/duration:
- ON day 28 of the study animals were challenged
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5
- Details on study design:
- Animals were sensitised by 6 percutaneous applications of the test substance using the same skin area for each application. After a 14 day rest perios the animals were tested for hypersenitivity. 24 and 48 hours after the challenge the reactions were assessed for the development of Erythema (score 0-4)
- Positive control substance(s):
- yes
- Remarks:
- Benzyl penicillin
- Positive control results:
- 9/10 and 10/10 animals treated with the positive control gave positive results at 48 hours
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Not available
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Not available
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not available
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not available
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- not specified
- Total no. in group:
- 5
- Remarks on result:
- other: no results provided
- 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 10% of the animals showed positive responses to the challenge after 48 hours, while this is not 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 the concentration of 4% w/v applied is significantly lower that the Buehler tet requirements and therefore is considered to be a skin sensitiser - Endpoint:
- skin sensitisation: in chemico
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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