Registration Dossier
Registration Dossier
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EC number: 271-603-6 | CAS number: 68586-02-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- According to hydrolysis test results, the hydrolysis rate is estimated to be within 30 minutes. The hydrolysis products have been identified to be ethanol, 2-propanol, acetylacetone and titanium dioxide.
The properties of the target substance would lie in the hydrolysis products. - Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Mouse ear swelling test. Substance applied to mouse ear with adjuvant with measure of subsequent swelling used to indicate hypersensitivity.
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Vehicle:
- unchanged (no vehicle)
- No. of animals per dose:
- 10
- Key result
- Parameter:
- other: ear swelling
- Value:
- ca. 26.94
- Variability:
- 1.02
- Test group / Remarks:
- male
- Key result
- Parameter:
- other: ear swelling
- Value:
- ca. 24.3
- Variability:
- 1.38
- Test group / Remarks:
- female
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An ear swelling study was used to examine the skin sensitising potential of ethanol. Ethanol was concluded as not sensitizing under conditions of this study.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
According to hydrolysis test results, the hydrolysis rate is estimated to be within 30 minutes. The hydrolysis products have been identified to be ethanol, 2-propanol, acetylacetone and titanium dioxide.
The properties of the target substance would lie in the hydrolysis products.
Ehtanol, 2 -propanol are classified as non-senstising according to CLP databased.
There is no reliable existing studies on 2,4-PD regarding sensitization. One reliable study indicated not sensitizing (Disseminated dossier, Source: European Chemicals Agency, http: //echa. europa. eu/)
Based on these findings, the target substance was considered not skin sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The target substance is not classified as skin sensitizer according to CLP Regulation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
