Registration Dossier
Registration Dossier
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EC number: 223-225-8 | CAS number: 3775-29-9
Endpoint summary
Administrative data
Description of key information
Skin Sensitisation In Vivo LLNA: GHS criteria not met. The test item was considered to be a non-sensitizer under the conditions of the test.
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
- 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)
- Version / remarks:
- (adopted 22 July 2010)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 20160308 (-88)
- Expiration date of the lot/batch: 31 March 2019
- Purity: 99.7%
- Storage condition of test material: room temperature in the dark - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc.,
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: suspended solid floor polypropylene cages furnished with
softwood woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50% (v/v)
- No. of animals per dose:
- 5
- Key result
- Parameter:
- SI
- Value:
- 1.32
- Test group / Remarks:
- Concentration (%v/v) in acetone/olive oil 4:1 = 10
- Remarks on result:
- other: Negative
- Key result
- Parameter:
- SI
- Value:
- 2.91
- Test group / Remarks:
- Concentration (%v/v) in acetone/olive oil 4:1 = 25
- Remarks on result:
- other: Negative
- Key result
- Parameter:
- SI
- Value:
- 2.88
- Test group / Remarks:
- Concentration (%v/v) in acetone/olive oil 4:1 = 50
- Remarks on result:
- other: Negative
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be a non-sensitizer under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
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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