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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to national standard, basic data given; comparable to guideline study, acceptable for assessment, but due to reduced observation time (only 7 days) persistence of irritating effect cannot be assessed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Code of Federal Regulations - 16 CFR 1500.42
Deviations:
yes
Remarks:
; three different test groups of three animals each differing in exposure time, longer observation period
Principles of method if other than guideline:
The general method used corresponds to OECD TG 405 (1981), but observation time is only 7 days.
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): X489-17B
- no further information

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 to 2.5 kg
- Housing: individually
- animals were maintained in accordance with standard laboratory procedure

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL neat test substance
Duration of treatment / exposure:
Group I: 2 seconds
Group II: 4 seconds
Group III: 24 hours (no washing)
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 per group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes for two of the three test groups
- Time after start of exposure: group I after 2 seconds, group II after 4 seconds, group III no washing

SCORING SYSTEM: scoring according to Draize (maximum score 110)

TOOL USED TO ASSESS SCORE: no data

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: observation time only 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: observation time only 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, and 72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: observation time only 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, and 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: scores were the same for all 3 animals; observation time only 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, and 72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: scores were the same for all 3 animals; observation time only 7 days

Any other information on results incl. tables

In the study report, scores are reported following the scoring system of Draize. The following tables display data which have been extracted from the report adapting them to the scoring system of test guideline EU B.5./OECD 405.

 

Eye reaction grading of group III animals (no washing of eyes)

 

Ocular Lesion

Animal #

24 h

48 h

72 h

Mean
(24 - 72 h)

4 d

7 d

Cornea

1

2

3

1

2

2

1

2

1

1

2

1

1

2

1.33

1

2

1

1

1

1

Iris

1

2

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

1

2

3

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

Chemosis

1

2

3

3

3

3

2

2

2

2

2

2

2.33

2.33

2.33

2

2

2

2

2

2

 

Eye reaction grading of group II animals (washing of eyes after 4 seconds)

 

Ocular Lesion

Animal #

24 h

48 h

72 h

4 d

7 d

Cornea

1

2

3

1

1

1

1

1

1

1

1

1

1

1

1

1

0

1

Iris

1

2

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

1

2

3

2

2

2

2

2

2

2

2

2

2

2

2

2

2

1

Chemosis

1

2

3

2

3

2

2

2

1

2

2

1

2

2

1

2

2

2

 

Eye reaction grading of group I animals (washing of eyes after 2 seconds)

 

Ocular Lesion

Animal #

24 h

48 h

72 h

4 d

7 d

Cornea

1

2

3

1

0

1

1

0

1

1

0

1

1

0

1

1

0

0

Iris

1

2

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

1

2

3

2

2

2

2

2

1

2

2

1

2

2

1

1

1

1

Chemosis

1

2

3

2

2

2

1

1

1

1

1

1

1

1

1

1

1

1

 

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
When applied to the eyes of rabbits and under the conditions of the test used, monoisopropylbiphenyl caused some moderate eye irritation which was not fully reversible within 7 days (duration of observation period). As there was no substantial decrease of eye irritation from day 3 to day 7, reversibility of the eye irritating effect within three weeks cannot definitely be assessed.