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Diss Factsheets

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
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:
1979
Report date:
1979

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
Chemical structure
Reference substance name:
2-(methylamino)ethanol, compound with sulphur dioxide
EC Number:
244-169-0
EC Name:
2-(methylamino)ethanol, compound with sulphur dioxide
Cas Number:
21049-70-7
Molecular formula:
C3H9NO.xO2S
IUPAC Name:
(oxo-λ⁴-sulfanylidene)oxidane; 2-(methylamino)ethan-1-ol
Details on test material:
- Name of test material: Kauramin-Härter CE 5162 flüssig; N-Methyläthanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 49.4 %, Sulfur dioxide: 29.5 %, Water: 21.1 %

Test animals / tissue source

Species:
rabbit
Strain:
other: albino (no further specification provided)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult (based on body weight)
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cage without bedding material
- Diet: standard pelleted feed for rabbits, ad libitum
- Water: ad libitum
- Acclimation period: more than 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours dark / 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as negative control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72 hours after application; the study was terminated after the 72-hour reading
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
SCORING SYSTEM:
Draize scoring system
Based on the Draize scores, a primary irritation index was calculated (max. score: 110)
The derived irritation index was evaluated as follows:
Index intervals 0 -10: no irritant, 11 -25: weak irritant, 26 -56: moderate irritant, 57 -110: strong irritant.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animals #1-6)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animals #1-6)
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:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: scores: 1/0/0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #4)
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: scores: 1/0/0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: scores: 1/0/0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: scores: 1/0/0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animals #1-6)
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight conjunctival redness was the only test substance-related finding. This transient finding was noted at the 1-hour and 24-hour readings in 6/6 and 4/6 rabbits, respectively. The mean score (24/48/72 hours) for conjunctival redness was 0 in 2/6 rabbits and 0.3 in the remaining 4/6 rabbits.
The primary irritation index was calculated to be 0.44. The test substance was no irritant to the rabbit eye.

Applicant's summary and conclusion

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