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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
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:
1979
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

Constituent 1
Reference substance name:
Morwet B
IUPAC Name:
Morwet B
Test material form:
solid: granular
Details on test material:
Material: Petrochemicals Company, Inc. - Morwet B
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 opacity1 and iris score1 for all animals, and conjunctival redness2 for 4/6 animals.

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