Registration Dossier
Registration Dossier
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EC number: 216-904-5 | CAS number: 1694-31-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-02-26 - 1985-03-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline and GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acetessigsäure-tert.butylester
- IUPAC Name:
- Acetessigsäure-tert.butylester
- Reference substance name:
- t-Butyl-acetoacetate
- IUPAC Name:
- t-Butyl-acetoacetate
- Test material form:
- other: liquid
- Details on test material:
- Product no.: IMAH 005
Appearance: liquid, clear
Storage: at 22°C, under the hood, in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Examination of the eyes was made after 1, 24, 48 and 72 hours after instillation. Observation of the eyes was aided by the use of a ophthalmoscops.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Other effects:
- Until 24 hours conjunctival reddening and a slight swelling was noticed. All reactions had resolved after 48 hours after instillation.
Any other information on results incl. tables
Animal No. |
1 |
2 |
3 |
|||||||||
hours/days |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area |
|
0 |
|
0 |
|
0 |
|
|
|
0 |
|
|
(F x E) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
D = Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
D x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
2 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C = Discharge |
|
|
|
|
|
|
|
|
|
|
|
|
(A + B + C) x 2 |
4 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
Total |
4 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
Group mean score at 1h: 4 Group mean score at 72h: 0
Group mean score at 24h: 2 Maximum mean score: 4
Group mean score at 48h: 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the rabbit eye.
- Executive summary:
The study was performed 1985, according to OECD-testing guideline and amended in year 1993 (Addendum to Lonza Report No. 2006).
Three New Zealand White strain albino rabbits were chosen in this test.
The test substance was administered unchanged in the conjunctival sac of the left eye.
Examination of the eyes were made after 1, 24, 48 and 72 hours after instillation. Conjunctival reddening and a slight swelling was noticed. All reactions had resolved 48 hours after instillation.Therefore, the test item will be not classified as eye irritant to the rabbit eye according to Regulation (EC) 1272/2008.
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