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EC number: 278-859-8 | CAS number: 78181-99-4
Eye irritation
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: Comparable to guideline study with acceptable restrictions (non-GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FED. REG. 38, NO. 187, PARA. 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- preparation containing CAS 78181-99-4
- IUPAC Name:
- preparation containing CAS 78181-99-4
- Details on test material:
- Please refer to confidential details on test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Weight at study initiation: mean males: 2.91 kg, female 2.85 kg
- Housing: single housing, cage area 43 cm x 51 cm
- Diet: approx. 130 g/day, Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf
- Water: approx. 250 mL/day; monday - friday VE water; saturday & sunday tap water
- Acclimation period: approx. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): approx. 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- not specified (single administration, no removal of test material by washing)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 rabbit (3 males, 3 females)
- Details on study design:
- SCORING SYSTEM:
according to Draize (APPRAISAL OF THE SAFETY OF CHEMICALS IN FOODS, DRUGS AND COSMETICS. IN: DERMAL TOXICITY PP. 46 - 59, 1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Conjunctival redness was the main finding after treatment with the test substance seen in all rabbits with the mean score (24, 48, 72 hours) ranging from 0.6 to 1.6. Chemosis was noted in 3/6 rabbits with a mean score of each 0.3. Effects on the iris was noted in one rabbit only (score 0.3). The findings were fully reversible within the observation period with the exeption of corneal opacity (score 1) seen in 1/6 rabbits on day 8.
For details, see table below.
Any other information on results incl. tables
Irritation scores:
Timepoint |
Animal No. |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
24 h |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
1 |
|
3 |
0 |
0 |
0 |
2 |
0 |
1 |
|
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
5 |
0 |
0 |
0 |
2 |
0 |
0 |
|
6 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
5 |
0 |
0 |
0 |
2 |
1 |
1 |
|
6 |
0 |
0 |
0 |
2 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
0 |
0 |
0 |
1 |
0 |
1 |
|
5 |
0 |
0 |
0 |
1 |
0 |
1 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
1 |
3 |
0 |
0 |
0 |
0 |
|
Mean 24h, 48h, 72h |
0 |
0 |
0.06 |
1.1 |
0.17 |
0.44 |
|
Mean (24h,48h,72h) |
Cornea Opacity |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
Animal 1 |
0 |
0 |
0.6 |
0.3 |
Animal 2 |
0 |
0.3 |
1 |
0.3 |
Animal 3 |
0 |
0 |
1.3 |
0 |
Animal 4 |
0 |
0 |
1 |
0 |
Animal 5 |
0 |
0 |
1.6 |
0.3 |
Animal 6 |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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