Registration Dossier
Registration Dossier
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EC number: 262-967-7 | CAS number: 61788-32-7
Skin irritation / corrosion
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- other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.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:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Terphenyl, hydrogenated
- EC Number:
- 262-967-7
- EC Name:
- Terphenyl, hydrogenated
- Cas Number:
- 61788-32-7
- Molecular formula:
- C18Hn (n >18-36)
- IUPAC Name:
- Terphenyl, hydrogenated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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