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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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, acceptable for assessment, but does not meet important criteria of today standard methods (see below under Principles)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations - 16 CFR 1500.41
Deviations:
no
Principles of method if other than guideline:
Overstringent test conditons, but evaluable in this case.
Shortcomings of the study design: cover of exposure site occlusive, exposure 24 h, observation time 72 h, number of readings 2, limited reporting
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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

Type of coverage:
occlusive
Preparation of test site:
other: two exposure areas at the trunk of the animals, one area clipped free of hair and one area clipped and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL neat test substance
Duration of treatment / exposure:
24 hours (animals were kept immobilised in an animal holder)
Observation period:
48 hours (after end of treatment)
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: one square inch (6.25 cm²); 2 sites on each animal (abraded and nonabraded skin)
- Type of wrap if used: gauze patch held in place with Dermicel tape; during the 24h exposure period, the trunks of the test animals were wrapped with rubberised cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM
- according to Draize (equivalent to Table 1 of OECD TG 404: 1981)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 0 and 48 h after patch removal
Score:
2.5
Max. score:
8
Reversibility:
no data

Any other information on results incl. tables

Skin reaction scores from nonabraded skin at the end of exposure period/patch removal (time 0) and 48 h after patch removal

 

Animal Number

Erythema and Eschar Formation

Oedema Formation

0 h

48 h

mean

0 h

48 h

mean

1

1

2

1.5

2

1

1.5

2

1

2

1.5

2

1

1.5

3

1

1

1

1

1

1

4

1

1

1

1

1

1

5

1

1

1

2

1

1.5

6

1

1

1

1

1

1

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With regard to the stringency of exposure conditions (24 h, occlusive) and only slight to moderate irritation response (scores <= 2), it is concluded that the irritating potency of isopropylbiphenyl is low and does not meet the classification requirements of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.