(1-methylethyl)-1,1'-biphenyl

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

(1-methylethyl)-1,1'-biphenyl

EC Number:

247-156-8

EC Name:

(1-methylethyl)-1,1'-biphenyl

Cas Number:

25640-78-2

Molecular formula:

C15H16

IUPAC Name:

(1-methylethyl)-1,1'-biphenyl

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

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

2

Results 5

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

Results 6

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.