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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:
06.05.1987 to 12.05.1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP. The restrictions were that the report lacks details on the identity and purity of the test substance.

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)
Deviations:
yes
Remarks:
incomplete details on the identity and purity of the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, GERMANY
- Age at study initiation: 6 months
- Weight at study initiation: 2.0-2.4 kg
- Diet: Standard diet used, but no indication of whether it was ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1987-05-06 To: 1987-05-12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: n/a - neat
Duration of treatment / exposure:
Single application
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
Unclear if eyes were washed following treatment.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Total score 10.4 (out of a total possible of 110) was judged, in the report, to fall within the range 0-10 indicating no irritation.
Other effects:
The report notes that no systemic toxicity was detected.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility*

Cornea

Iris

Conjunctivae

Opacity - Max. score 4 (a)

Area - Max. score 4 (b)

Max. - score 2 (c)

Redness - Max score 3 (d)

Chemosis - Max. score 4 (e)

Discharge -Max. score 3 (f)

60 min

0/0/0

0/0/0

0/0/0

2/3/3

0/2/0

0/1/1

24 h

0/1/0

0/4/0

0/1/0

1/3/2

0/2/0

0/1/0

48 h

0/1/0

0/4/0

0/0/0

0/3/2

0/1/0

0/0/0

72 h

0/1/0

0/4/0

0/0/0

0/2/1

0/0/0

0/0/0

Average 24h, 48h, 72h

1

 1.3

 0.1

1.6

0.3

0.1

Mean scores (3 animals; 4 time points) out of maximum possible

5/80

0.4/10

5/20

Total score** (max 110)

10.4/110

*Each entry shows values for each of the 3 animals

**Maximum total score = [axbx5] + [cx5] + [(d+e+f)x2]=110

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A reliable eye irritation study, conducted according to OECD 405 but not GLP, reported a Draize score of 10.4 out of 110. The score was judged in the report to indicate that the test material was not irritating to the eyes of rabbits. This finding would concur with a reading according to EU criteria.