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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:
1980
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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Qualifier:
equivalent or similar to guideline
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

Constituent 1
Reference substance name:
Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
IUPAC Name:
Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
Details on test material:
- Name of test material: Kauramin-Härter CE 5196 flüssig; N-Methyläthanolammonium(-hydrogen) sulfit + Äthanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 21 %, Ethanolamine: 24.6 %, Sulfur dioxide: 35 %, Water: 19.4 %
- Other: pH-neutral mixture

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: 50 µL (not indicated in the report; standard volume used in the BASF test)
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:
3 rabbits
Details on study design:
SCORING SYSTEM:
Draize scoring system
Based on the Draize scores, a primary irritation index was calculated (max. score: 110/9).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #1)
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
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #1)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #3)
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:
1
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: scores: 1/1/1
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: scores: 1/1/1
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: scores: 1/1/0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #1)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight conjunctival redness was the only test item-related finding noted. The mean scores (24/48/72 hours) for this endpoint were 1 in 2/3 rabbits and 0.7 in the remaining rabbit. Reversibility was not reported; however, 1/3 rabbits showed no signs of conjunctival redness at the 72-hour reading.
The primary irritation index was calculated to be 1.8.

Applicant's summary and conclusion

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

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