Registration Dossier
Registration Dossier
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EC number: 939-689-6 | CAS number: -
Eye irritation
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:
- 1 980
- 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
- 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
Constituent 1
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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