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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Mixture of hydrogenated terphenyls
- Physical state: Yellow liquid
- Impurities (identity and concentrations): 0.15% phenyl cyclohexane and 6.79% high boilers

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isaac's Farm Isf
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 1.91-2.90 kg
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL to each application site
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
6 rabbits (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: one inch square, two sites
- Type of wrap if used: latex rubber

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped
- Time after start of exposure: 24 hours

SCORING SYSTEM: Primary irritation index (Draize procedure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24,72 hours
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24,72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24,72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Mean PDI = 0.1 on a scale of 8
Executive summary:

A primary irritation score (mean of 24 and 72h) of 0.1 on a scale of 8.0 was calculated following a 24-hour dermal exposure of hydrogenated terphenyl to the intact and abraded skin of six rabbits. No apparent signs of systemic toxicity were observed.