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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:
April 1987 - May 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The irritant potential of four amphoteric surfactants was assessed.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
The test substance was used with adjusted 25% active matter.

Test animals / tissue source

Species:
rabbit
Strain:
other: chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 2115.0 to 2412.5 g
- Sex: males

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
0.1 ml of test substance (25% active matter)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 6, 24, 48, 72 h and 7, 10, 14, 17, 21 days
Number of animals or in vitro replicates:
four animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- not specified

SCORING SYSTEM: The reactions on cornea, iris and conjunctiva were assessed according to the scoring system by Draize.

TOOL USED TO ASSESS SCORE: 0.5% fluorescein solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: opacity area
Basis:
animal #3
Time point:
21 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
other: opacity area
Basis:
animal #4
Time point:
21 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
other: opacity area
Basis:
animal #1
Time point:
21 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Corneal reactions which persisted for 21 days were observed in three test animals treated with the test substance. One animal treated with the test substance revealed irreversible corneal damage after 21 days. Reactions to the iris were not observed. Conjunctival reactions were severe and persisted for 21 days after application in the majority of test animals (3/4) when rabbits were treated with the test substance.

Any other information on results incl. tables

Table 1: Corneal reactions to rabbit eyes after application of the test substance with 25% active matter

Animal number

Hours after application

Days after application

1

6

24

48

72

7

10

14

17

21

A

B

A

B

A

B

A

B

A

B

A

B

A

B

A

B

A

B

A

B

543

0

0

1

2

1

4

1

4

1

3

1

2

1

1

1

1

1

1

1

1

588

1

2

1

2

1

4

1

4

1

4

1

2

1

2

0

0

0

0

0

0

589

1

2

1

2

1

4

1

4

1

4

1

4

1

4

1

4

1

4

1

4

590

1

2

1

4

1

4

1

4

1

4

1

4

1

4

1

4

1

4

1

4

A (mean)

0.75

1.00

1.00

1.00

1.00

1.00

0.75

0.75

0.75

0.75

B (mean)

1.50

2.50

4.00

4.00

3.75

3.00

2.75

2.25

2.25

2.25

A = opacity grade; B = opacity area

Table 2: Conjunctiva reactions to rabbit eyes after application of the undiluted test substance

Animal number

Hours after application

Days after application

1

6

24

48

72

7

10

14

17

21

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

543

1

2

3

1

2

3

2

1

3

3

2

3

3

1

3

2

1

3

1

0

1

1

0

1

0

0

1

0

0

0

588

1

1

3

1

1

3

3

1

3

3

1

3

3

1

3

2

1

3

2

0

3

2

0

1

2

0

1

1

0

3

589

2

1

3

1

1

3

2

1

3

3

1

3

3

1

3

3

1

3

3

1

3

2

0

1

2

0

2

2

0

1

590

1

2

3

2

1

3

3

1

3

2

1

3

2

1

3

2

0

1

2

0

1

2

0

1

2

0

1

1

0

3

A (mean)

0.75

1.00

1.00

1.00

1.00

1.00

0.75

0.75

0.75

0.75

B (mean)

1.50

2.50

4.00

4.00

3.75

3.00

2.75

2.25

2.25

2.25

A = erythema; B = chemosis; C = exudation;  red bold = bloody; bold = bloody infiltrated

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The results generated by the performed study concludes the test substance to be severly irritant to the mucous membrane of the eyes with irreversible damages to the cornea and the conjuctiva. Thus, the test substance must be labelled with the R-phrase R-41.
Executive summary:

Three amphonic surfactants and the test substance wre tested in a concentration of 25% active ingredient for their primary eye irritation on rabbits by a single application and permanent contact (Method: Off. J. Europ. Commun. 27, L 251, 1984 p. 109 - 112 and Guidelines for Testing of Chemicals, Section 4, No 405, OECD). In each group were animals with corneal lesions, which had to be regarded as irreversible. All 4 test samples had to be signed with the risk phrases R-41.