Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Reference:
Composition 1
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 information:
Composition 1
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
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
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

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

 

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

MIPB is slightly to moderately irritating to the rabbit´s eye. There were no significant but only slight signs of erythema at skin site of rabbits treated for 24 h. This implies no effect will be anticipated after 4h exposure.


Justification for selection of eye irritation endpoint:
Study with grade of effects relevant for classification, second study showing no effects that require classification.

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Irritation effects on the eye were eventually serious enough to trigger classification, while no classification for skin irritation is required.