Registration Dossier
Registration Dossier
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EC number: 201-116-6 | CAS number: 78-42-2
Endpoint summary
Administrative data
Description of key information
Skin sensitsation = not sensitising; non-guideline study - drop on test; Anon. (1990)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline study or GLP; limitations (No. of animals, course of experiment unclear, control substance not defined) .
- Principles of method if other than guideline:
- other: no data concerning method
- GLP compliance:
- not specified
- Type of study:
- other: Drop on test
- Justification for non-LLNA method:
- The study pre-dates LLNA mathodology becoming validated by ECVAM and published as an OECD Guideline.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Reading:
- other: See 'other information on results inc. tables' for details of experimental readings
- Group:
- test chemical
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- See 'any other information on results inc. tables'
- Reading:
- other: See 'other information on results inc. tables' for details of experimental readings
- Group:
- positive control
- Dose level:
- Phenylhydrasine control
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- See 'any other information on results inc. tables'
- Reading:
- other: See 'other information on results inc. tables' for details of experimental readings
- Group:
- negative control
- Dose level:
- solvent control
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- See 'other information on results inc. tables'
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be not sensitizing in this test system.
- Executive summary:
In an old and very limited study not performed according actual guideline methods (Drop on test) the compound was tested in 5 guinea pigs (no further details about the method given). Solvent control (compound not specified) and positive control (Phenylhydrasine) was applied. The test substance, the solvent control and the positive control was evaluated with an initial score after 24 hours and after 48 hours. Also a final score was evaluated after 24 and 48 hours. The test substance was found to be not sensitizing in this test system.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available (carried out before 11 October 2016)
Referenceopen allclose all
Results:
| Solution | No.of animals (Guinea Pig) | Type of Test | Initial score | Final score | ||
| Skin sensitizytion | 24 hrs | 48 hrs | 24 hrs | 48 hrs | ||
| Test substance Intramuscularly in A:D:CO | 5 | Drop on | 1.0 | 0.6 | 1.0 | 0.9 |
| Phenylhydrasine control | 5 | Drop on | 1.0 | 1.4 | 3.4 | 2.3 |
| Solvent control | 5 | Drop on | 1.0 | 0.8 | 1.2 | 0.6 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In an old and very limited study not performed according actual guideline methods (Drop on test) the compound was tested in 5 guinea pigs (no further details about the method given).
Solvent control (compound not specified) and positive control (Phenylhydrasine) were included in the experiment and gave the expected results.
The test substance, the solvent control and the positive control was evaluated with an initial score after 24 hours and after 48 hours. Also a final score was evaluated after 24 and 48 hours.
The test substance was found to be not sensitizing in this test system (Eastman Kodak Co, 1990).
Conclusion: The test item exhibits no skin-sensitization potential in a ´Drop on test´.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No respiratory sensitization study is available.
Justification for classification or non-classification
The substance does no meet the criteria for classification in accordance with Regulation (EC) No 1272/2008 (CLP).
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