Registration Dossier
Registration Dossier
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EC number: 940-644-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- other: Read-across & category approach
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Category is coherent for more than 10 endpoints. Eye irritation was assessed using 11 OECD-405 studies and 2 OECD-407 studies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
- Principles of method if other than guideline:
- Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and grouping of chemicals - May 2008.
- GLP compliance:
- no
- Remarks:
- Not relevant for category approach
Test material
- Reference substance name:
- D-pentose, oligomeric, C10 and C12 alkyl glycosides
- EC Number:
- 940-644-8
- IUPAC Name:
- D-pentose, oligomeric, C10 and C12 alkyl glycosides
Constituent 1
Results and discussion
In vivo
Results
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: day-1
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: APP-10-dp2, see APP report
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on 11 OECD-405 and 2 OECD-407 studies, APP with short alkyl chain appear as borderline between eye irritation/damage cat. 2 and 1. Strict application of CLP rules drive a classification 1, as this classification may be very conservative, an SCL is proposed.
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