Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
Prior to implementation of GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data.

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 h
Observation period (in vivo):
14 days. However only data for 6 days were available.
Number of animals or in vitro replicates:
9 (6 unwashed; 3 washed directly after application)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With lukewarm physiological NaCl solution
- Time after start of exposure: 72 h after application

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only unwashed animals were regarded for calculation.
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Only unwashed animals were regarded for calculation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0.4
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Only unwashed animals were regarded for calculation. Score represents a worst case, since individual scores for conjunctivae and chemosis are not given.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only unwashed animals were regarded for calculation. Score represents a worst case, since individual scores for conjunctivae and chemosis are not given.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met