Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid without restriction. Well documented GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
EPA Guideline 81-4
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye was left untreated as a negative control.
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, 72, and 168 hrs.
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: 6
Other effects:
No lesions observed
One hour after application, all six animals animal were positive for conjunctival symptoms and two animals showed iris effects. Maximum irritation effects
were seen at 24 hrs (group mean score 22.5/110) when corneal opacity was also observed in five animals.
After 168 hours, only one animal showed irritation effects. The scores for each animal at each reading, and the mean score for each animal are shown in the
tables below.

Any other information on results incl. tables

Group Mean Scores for Ocular Lesions (Draize values)

Rabbit No.

 

1 hr.

24 hrs.

48 hrs.

72 hrs.

168 hrs. (7 days)

611

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

0

 

2

2

2

 

1

2

1

 

2

2

3

 

0

0

0

 

2

1

1

 

0

0

0

 

2

1

1

 

0

0

0

 

0

0

0

612

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

 

 

--

--

0

 

2

2

2

 

1

1

0

 

2

2

3

 

0

0

0

 

2

1

1

 

0

0

0

 

1

1

1

 

0

0

0

 

0

0

0

613

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

1

 

2

2

2

 

1

3

1

 

2

2

3

 

1

1

0

 

2

1

1

 

0

0

0

 

1

1

1

 

0

0

0

 

0

0

0

614

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

0

 

2

1

1

 

1

1

0

 

2

1

2

 

0

0

0

 

1

0

0

 

0

0

0

 

1

0

0

 

0

0

0

 

0

0

0

615

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

0

 

1

1

1

 

0

0

0

 

2

1

1

 

0

0

0

 

1

0

0

 

0

0

0

 

1

0

0

 

0

0

0

 

0

0

0

616

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

1

 

2

2

2

 

1

3

1

 

2

2

3

 

1

1

0

 

2

1

1

 

0

0

0

 

2

1

1

 

0

0

0

 

0

0

0

Group Mean Scores for Ocular Lesions (Draize values)

Average

1 hr.

24 hrs.

48 hrs

72 hrs.

168 hrs

Cornea

--

8.3

1.7

0.0

0.0

Iris

1.7

2.5

0.0

0.0

0.0

Conjunctiva

10.3

11.7

5.0

4.7

0.0

Total

12.0

22.5

6.7

4.7

0.0

Applicant's summary and conclusion

Interpretation of results:
Category III
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD No. 405 (1987) and EPA Guideline 81-4
Conclusions:
EPA/OECD Toxicity Category III for eye effects – corneal involvement or irritation clearing in 7 days or less.