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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:
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

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

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.