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EC number: 272-716-3 | CAS number: 68909-83-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study period: Between 20 Nov 1978 and 27 Nov 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- The methods employed in the testing, evaluation and in the grading of the test material are those described in Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973.
- Deviations:
- no
- Principles of method if other than guideline:
- 0.1 mg of unwetted material was instilled in the right eyse of 6 albino rabbits. The material was not washed from the eyes. Observations were made up[ to 7 days after installation.
Evaluations were done according to Draize, involving the same elements as OECD 405 grading. - GLP compliance:
- not specified
- Remarks:
- Study from before GLP
Test material
- Reference substance name:
- Morwet B
- IUPAC Name:
- Morwet B
- Test material form:
- solid: granular
- Details on test material:
- Material: Petrochemicals Company, Inc. - Morwet B
Constituent 1
- Specific details on test material used for the study:
- Commercial product.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Six healthy young adult albino rabbits.
No futher infomation
Test system
- Amount / concentration applied:
- Test material was used as supplied. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls.
- Duration of treatment / exposure:
- The test material was not washed from the eyes.
- Observation period (in vivo):
- Up to 7 days.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- Draize scoring system was applied
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- Expected full reverisble within 21 days.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.44
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- Expected full reverisble within 21 days.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.94
- Max. score:
- 3
- Reversibility:
- other:
- Remarks:
- Expected full reverisble within 21 days.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- other:
- Remarks:
- Expected full reverisble within 21 days.
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Scoring:
| cornea | Iris | Conjunctivae | |||||
| Time | rabbit | opacity | area | redness | Chemosis | Discharge | |
| 1 hour | 1 | 1 | 4 | 1 | 3 | 3 | 3 |
| 2 | 2 | 4 | 2 | 3 | 3 | 3 | |
| 3 | 1 | 4 | 1 | 3 | 3 | 3 | |
| 4 | 1 | 4 | 1 | 3 | 3 | 3 | |
| 5 | 2 | 4 | 2 | 3 | 3 | 3 | |
| 6 | 1 | 4 | 1 | 3 | 3 | 3 | |
| 24 hrs | 1 | 2 | 4 | 1 | 2 | 3 | 3 |
| 2 | 3 | 4 | 2 | 2 | 4 | 3 | |
| 3 | 2 | 4 | 2 | 3 | 4 | 3 | |
| 4 | 2 | 4 | 2 | 2 | 3 | 3 | |
| 5 | 2 | 4 | 2 | 3 | 3 | 3 | |
| 6 | 2 | 4 | 2 | 3 | 4 | 3 | |
| 48 hrs | 1 | 1 | 4 | 1 | 2 | 2 | 2 |
| 2 | 2 | 4 | 2 | 2 | 2 | 2 | |
| 3 | 2 | 4 | 1 | 2 | 2 | 2 | |
| 4 | 2 | 4 | 1 | 2 | 2 | 2 | |
| 5 | 2 | 4 | 1 | 2 | 2 | 2 | |
| 6 | 2 | 4 | 2 | 2 | 2 | 2 | |
| 72 hrs | 1 | 1 | 4 | 1 | 1 | 2 | 1 |
| 2 | 2 | 4 | 1 | 2 | 2 | 2 | |
| 3 | 1 | 4 | 1 | 1 | 1 | 1 | |
| 4 | 1 | 4 | 1 | 1 | 1 | 2 | |
| 5 | 1 | 4 | 1 | 1 | 1 | 2 | |
| 6 | 2 | 4 | 2 | 2 | 2 | 2 | |
| 5 days | 1 | 0 | 0 | 0 | 1 | 1 | 1 |
| 2 | 1 | 4 | 1 | 1 | 1 | 2 | |
| 3 | 0 | 0 | 0 | 1 | 1 | 1 | |
| 4 | 0 | 0 | 0 | 1 | 1 | 1 | |
| 5 | 0 | 0 | 0 | 1 | 1 | 1 | |
| 6 | 1 | 4 | 0 | 1 | 1 | 2 | |
| 7 days | 1 | 0 | 0 | 0 | 1 | 1 | 1 |
| 2 | 0 | 0 | 0 | 0 | 1 | 1 | |
| 3 | 0 | 0 | 0 | 0 | 1 | 0 | |
| 4 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 5 | 0 | 0 | 0 | 1 | 1 | 1 | |
| 6 | 0 | 0 | 0 | 0 | 1 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- 0.1 mg in the eyes of 6 rabbits resulted to clear signs of irritation in all rabbits, which was maximal at 24 hours and gradually declined afterwards.
- Executive summary:
Morwet B (Naphthalenesulfonic acid, methyl, butyl, sodium salt) was evaluated for eye irritation in the rabbit. Six healthy young adult albino rabbits were used in this study. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes.
The treated eyes were examined at 1, 24, 48 8 72 hours and 5 and 7 days following instillation of the test material into the eyes. Interpretation of the results was made in accordance to Draize, involving Cornea opacity (1-4) and area (1-4), iris (1-2) and Conjunctiva redness (1-3), chemosis (1-4) and discharge (1-3).
Below the average scores from the 6 animals over the observation period of 7 days.
Time
Cornea
Iris
Conjunctiva
redness
Chemosis
Discharge
1
1.3
1.3
3.0
3.0
3.0
24
2.2
1.8
2.5
3.5
3.0
48
1.8
1.3
2.0
2.0
2.0
72
1.3
1.2
1.3
1.5
1.7
120
0.3
0.2
1.0
1.0
1.3
168
0.0
0.0
0.5
0.8
0.5
Although most animals still show some effects on conjunctivae on day 7 (grade one on redness and/or chemosis and/or discharge), it can be expected that when the observation period was extended to 21 days, these will completely disappear. (See attached graph with observed average scores up to 168 hours / 7 days)
For evaluation for GHS classification, the averages for 24, 48 and 72 hours are calculated per animal:
rabbit
opacity
iris
redness
1
1.3
1.0
1.7
2
2.3
1.7
2.0
3
1.7
1.3
2.0
4
1.7
1.3
1.7
5
1.7
1.3
2.0
6
2.0
2.0
2.3
Calculating the averages for 24, 48 and 72 hours per animal, show that GHS criteria for Cat.2 are met with scores for corneal opacity≥1 and iris score≥1 for all animals, and conjunctival redness≥2 for 4/6 animals.
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