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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:
1977
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Draize, John H.: Dermal toxicity , Apraisal of the safety of Chemicals in Foods, Drugs and cosmetics, Association of food and drug officials of the U.S., 1959, pp.49-51
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
- Name of test material (as cited in study report): Diacid 1550, K-salt (trade name: "H-240 100%")
- Physical state: amber solid
- Storage condition of test material: At room temperature in original, sealed container

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
The animals were kept under observation at least 7 days prior to experimental use, during which period they were examined with respect to their general health and suitability as test animals. The animals were housed in suspended, wire bottomed steel cages and mantained on a standard laboratory diet. Food and water were offered ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
unlimited
Observation period (in vivo):
1, 24, 48, 72 h
7 and 14 days
Number of animals or in vitro replicates:
6
Details on study design:
The test material was instilled into the conjunctival sac of the right eye of each rabbit according to the treatment procedure. The left eye of each animal served as control. At each scoring interval the cornea, iris and palbebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system. The maximum possible score at any 1 examination and scoring period was 110 points, which indicated maximal irritation and damage to all 3 ocular tissues. Zero indicated no irritation. In this scoring system, special emphasis was placed upon irritation or damage to the cornea, while less emphasis was placed upon damage to the iris and conjuctiva.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
1.5
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
14 d
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0.67
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
14 d
Score:
0.34
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
14 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
2.17
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
2.33
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
2.83
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
2.66
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
2.5
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
14 d
Score:
1
Max. score:
4

Any other information on results incl. tables

After the completion of the test, the scores were analysed and an eye irritation classification was assigned to the test material. The criteria used for assignment of the classification were the frequency, the extent and the persistence of irritation or damage which occurred to the 3 ocular tissue.

The classification was obtained by selecting the maximum mean irritation score at 1, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury did not meet the requirements defined for the classification appropriate for a particular numerical score, the classification was raised by one or more levels.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test item (H-240 Potassium salt of Diacid 1550) is classified as severely irritating. An improvement of scores during the observation period was evident, showing signs of reversibility.