Registration Dossier
Registration Dossier
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EC number: 429-080-9 | CAS number: -
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- -
- EC Number:
- 429-080-9
- EC Name:
- -
- Cas Number:
- 198904-85-7
- Molecular formula:
- C17 H21 N3 O2
- IUPAC Name:
- Tert-butyl 2-[4-(2-pyridinyl) phenylmethyl] hydrazine carboxylate
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- Identity of test material same as for substance defined in section 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classifed
- Conclusions:
- The test material produced a 0% sensitisation rate to guinea pig skin.
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