Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study, no GLP, short report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technically pure

Test animals / tissue source

Species:
rabbit
Strain:
other: White Wiener
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BASF

- Weight at study initiation: ca. 2,3 kg ( mean)

- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
ca 50 mg
50% paste
Duration of treatment / exposure:
not limitd (no washing)
Observation period (in vivo):
8 days.
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: verbal report, no numbers given
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: verbal report, no numbers given
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 and 24 h
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: slight reddening was reported, no number given
Irritant / corrosive response data:
Slight reddening of the conjunctivae was observed at 1 and 24 Hours after treatment.
Other effects:
no other effects occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritant or corrosive on the eyes of two rabbits.
Executive summary:

Application of 50 mg/ animal on one eye of each rabbit caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.