Registration Dossier
Registration Dossier
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EC number: 429-080-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
A guinea pig maximisation study was carried out to determine the skin sensitisation potential of the substance BMS 233110-01. The substance (50% w/v) induced 0% allergic skin reaction in all animals that survived the 21 -day observation period (one control animal was lost). It is therefore considered to non-sensitising and does not meet the criteria for sensitisation in accordance to the CLP Regulation.
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:
- 16th Nov - 25th Dec 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted prior to the introduction of in-vitro and LLNA studies
- Specific details on test material used for the study:
- Identity of test material same as for substance defined in section 1
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not classifed
- Conclusions:
- The test material produced a 0% sensitisation rate to guinea pig skin.
Reference
Maximium concentration not causing irritating effects in preliminary test: 5%
Signs of irritation during induction: Very slight to well defined erythema was apparent at the injection sites of both test and control animals. Following topical exposure, most sites in the control and treated animals exhibited either very slight or well-defined erythema, with very slight oedema noted in some animals.
Evidence of sensitisation of each challenge concentration: There were no signs of reaction in any of the treated or control animals. 50% was considered to be the highest practical concentration possible to administer.
Other observations: One control animal was put down on day 16 having shown respiratory problems. No cause, but was considered not to be treatment related.
No other significant observations other than the dermal effects.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
0% sensitising at 50% tested concentration
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