Registration Dossier
Registration Dossier
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EC number: 911-428-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Cross-reference
- Reason / purpose for cross-reference:
- assessment report
Data source
Materials and methods
Test material
- Reference substance name:
- Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
- EC Number:
- 911-428-0
- IUPAC Name:
- Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
- Test material form:
- solid: flakes
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effects observed at any time
- Remarks on result:
- other: Montan wax, Type E
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable as no effects observed at any time
- Remarks on result:
- other: Montan wax, type E
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h;
- Remarks:
- individual mean scores 0, 0.33, 0.33; maximum score observed: 1
- Remarks on result:
- other: Montan wax, type E
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours;
- Remarks:
- grade 1 chemosis was observed at 1 hour post exposure
- Remarks on result:
- other: Montan wax, type E
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In reliable studies members of the category of Montan waxes (undiluted test materials) were not irritating to the eyes of rabbits.
- Executive summary:
The studies used as source investigated the eye irritating potential of members from the category of Montan waxes.
The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
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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