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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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Laboratory study in experienced laboratory.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male and female white New Zealand rabbits weight between 3.7 and 6.0 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single treatment that was not washed out.
Observation period (in vivo):
1, 24, 48, and 72 hours and at 6 days after application.
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, and 72 hrs and 6 days
Score:
46.9
Reversibility:
not fully reversible within: 6 days
Remarks on result:
other: moderately irritating
Irritant / corrosive response data:
Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.

Any other information on results incl. tables

 

Results of Eye Irritation Study in Rabbits

Observation

Endpoint

Male

11655

Male

11715

Male

11771

Female

11798

Female

11804

Female

11838

1 hr

Cornea ¿ degree

1

1

2

2

2

1

1 hr

Cornea ¿ range

4

4

4

4

4

4

1 hr

Iris

1X

1X

1X

1X

1X

1X

1 hr

Conjunctiva ¿ redness

3N

3N

3N

2N

3N

3N

1 hr

Conjunctiva ¿ edema

1

1

1

1

2

2

1 hr

Conjunctiva - exsudation

3

3

3

3

3

3

24 hrs

Cornea -degree

1

1

2

2

3C

1

24 hrs

Cornea ¿ range

4

4

4

4

2

4

24 hrs

Iris

1*

1*

1*

1*

1*-

1*

24 hrs

Conjunctiva ¿ redness

3N

3N

3N

3N

3N S

3N

24 hrs

Conjunctiva ¿ edema

2

2

2

2

2

3

24 hrs

Conjunctiva - exsudation

2

2

2

2

2

2

48 hrs

Cornea ¿ degree

1

1

2

2

3C

1

48 hrs

Cornea - range

4

4

4

4

2

4

48 hrs

Iris

1*

1*

1*

1*

1*-

1*

48 hrs

Conjunctiva ¿ redness

3N S

3N

3N S

3N S

3N S

3N S

48 hrs

Conjunctiva ¿ edema

2

1

1

1

2

3

48 hrs

Conjunctiva - exsudation

2

2

2

2

2

2

72 hrs

Cornea ¿ degree

1

1

1

2

4C

1

72 hrs

Cornea - range

4

2

4

4

2

4

72 hrs

Iris

1X

1X

1*

1*

1*-

1*

72 hrs

Conjunctiva - redness

3N S

3N S

3N S

3N S

3N S

3N S

72 hrs

Conjunctiva ¿ edema

2

2

2

2

2

2

72 hrs

Conjunctiva - exsudation

2

2

2

2

2

2

6 days

Cornea ¿ degree

2

2

2

2

4C

2

6 days

Cornea -range

3

3

2

3

2

4

6 days

Iris

1X

1X

1*

1*

1*-

1*

6 days

Conjunctiva - redness

3N S L

3N L

3N L H

3N S L

3N S L

3N S L

6 days

Conjunctiva ¿ edema

2

2

2

2

2

2

6 days

Conjunctiva - exsudation

2

1

2

2

2

2

C ¿ Cornea cloudy

X ¿ Parts of the iris turned red

* - Iris turned red

- - Retarded iris reaction

N ¿ Necrosis and corrosion of the conjunctiva

S ¿ Secretion formation

L ¿ Lids became encrusted

H ¿ Holding head inclined

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Result: moderately irritating
Executive summary:

The eyes of six rabbits were treated with the test substance and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.