Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study, comparable to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 405 was first adopted in 1981, eye irritation was tested using a BASF test.
The methods were based on Draize (Federal Register 38, No. 187, § 1500.42, p. 27019 (1973-09-27)).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Härter 421 flüssig; Äthanolaminhydrochlorid 45 % (German)
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 µL
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
not reported (the standard duration of the observation period in the BASF test on eye irritation was 7 or 8 days)
Number of animals or in vitro replicates:
6 rabbits (4 males, 2 females)
Details on study design:
SCORING SYSTEM:
Draize scoring system
Based on the Draize scores, a primary irritation index was calculated (max. score: 110).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animals #1, #3, #4, #6)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
0.33
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: finding noted at 72 hours only (score 1)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
0.33
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: finding noted at 72 hours only (score 1)
Irritation parameter:
iris score
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #1)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #4)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animals #1, #2, #3, #4, #5)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: finding noted at 24 hours only (score 2)
Irritant / corrosive response data:
Slight conjunctival redness was the main test substance-related finding noted in 5/6 rabbits with mean scores (24/48/72 hours) ranging from 0.67 to 1.33. In 1/6 animals chemosis was observed after 24 hours resulting in a mean chemosis score of 0.67 for this rabbit. In 2/6 rabbits a very slight corneal opacity was noted at the 72-hours reading resulting in a mean score (24/48/72 hours) of 0.33 for each of the two rabbits. Reversibility was not assessed in this study (no 8-day observation reported); however there was a general trend towards reversibility within the 72-hour observation period.

The primary irritation index was calculated to be 3.0.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU