Registration Dossier

Toxicological information

Eye irritation

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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:
2014

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
Name:
Unnamed
Type:
Constituent

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.