Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-09-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been assessed according to Klimisch scores.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Mol:Russian

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
according to guideline
Observation period (in vivo):
according to guideline
Number of animals or in vitro replicates:
3
Details on study design:
according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours mean
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours mean
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours mean
Score:
0.9
Max. score:
2
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registered substance is not irritating to the eyes
Executive summary:

The eye irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 405 under GLP conditions.

The amount of 0.1 ml of the undiluted substance was applied unchanged for 24 hours to the eyes of three Mol:russian rabbits, which were observed for 7 days post application. Over the first three days minimal effects on the conjunctiva were observed which did fully reverse within 3 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is not considered to be eye irritating.

Since the composition of the registered substance is almost identical to the test substance, only the amount of C12 and C14 epoxide is slightly lower in the registered substance, this key study is taken as a valid read across for this endpoint and the registered substance is also considered to be non irritating to the eye accordingly.