Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
The MAK Collection for Occupational Health and Safety
Author:
MAK Collection
Year:
2012
Bibliographic source:
MAK Value Documentation, 146–153, 2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An ocular irritation study was conducted for chemical on rabbits to determine adverse effects caused by the chemicals.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material: Diphenyl ether
- Molecular formula: C12H10O
- Molecular weight: 170.211 g/mol
- Substance type: Organic
- Physical state: Liquid
- Smiles: c1(Oc2ccccc2)ccccc1
-InChI:1S/C12H10O/c1-3-7-11(8-4-1)13-12-9-5-2-6-10-12/h1-10H

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
100mg
Duration of treatment / exposure:
single
Observation period (in vivo):
24 hours till 21 days
Number of animals or in vitro replicates:
3
Details on study design:
- Area of exposure: conjunctival sac

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The test chemical caused resulting corneal damage which persisted for more than 24 hours, but healed within 21 days.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test chemical caused resulting corneal damage which persisted for more than 24 hours, but healed within 21 days.
Hence, the test chemical can be considered to be irritating to eyes.
Executive summary:

An ocular irritation study was conducted to determine adverse effects caused by the chemical in rabbits

 

100mg of the test chemical was instilled into the eyes of 3 rabbits and observed for effects from 24 hours till 21 days.

The test chemical caused corneal damage which persisted for more than 24 hours, but healed within 21 days.

Hence, the test chemical can be considered to be irritating to eyes.