Registration Dossier
Registration Dossier
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EC number: 939-526-9 | CAS number: 90506-73-3
Endpoint summary
Administrative data
Description of key information
In an OECD 429 study, conducted according to GLP, the test material is not sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May to July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals were nulliparious and non-pregnant
At lease 5 days of acclimatisation provided
Weight: 15 to 23 g
Age: 8 to 12 weeks old
Animals individually housed in solid floor suspended cages.
Free access to food and tap water available for the animals.
The temperature and humidity were controlled to remain within the range 19 - 25ºC and 30 to 70% respectively. - Vehicle:
- other: Butanone
- Concentration:
- 25ul of solution with a concentration of 10, 5 & 2.5% w/w in butanone.
- No. of animals per dose:
- Four.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The positive control (85%) was considered to be a sensitiser under the conditions of the test.
- Parameter:
- SI
- Value:
- 1.99
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.45
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 2.66
- Test group / Remarks:
- 10%
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not sensitising.
Reference
Study completed at good quality European Union (EU) laboratory according to OECD Guideline 429 (Local Lymph node assay) and according to GLP. The Skin sensitization study determined that the test material was found to be a non-sensitizer under the conditions of the test.
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
In the key study the test material produced a Negative response in concentration groups 2.5%, 5% and 10% therefore, in accordance with Regulation No. 1272/2008 (amended in Regulation No. 286/2011) Table 3.4.2, the test material is not classified as a skin sensitiser.
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