Registration Dossier
Registration Dossier
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EC number: 283-810-9 | CAS number: 84713-17-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-10-01 to 1985-10-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2,4(or 2,4,4)-trimethylhexanedinitrile
- EC Number:
- 283-810-9
- EC Name:
- 2,2,4(or 2,4,4)-trimethylhexanedinitrile
- Cas Number:
- 84713-17-7
- Molecular formula:
- C9H14N2
- IUPAC Name:
- 2,2,4-trimethylhexanedinitrile; 2,4,4-trimethylhexanedinitrile
- Details on test material:
- 2,2,4(or 2,4,4)-Trimethylhexanedinitrile of Hüls AG, purity 96.5 %, main impurity 1-cyano-2-imino-3,5,5-trimethylcyclopentane = 2.42 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small white Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male and female
- Weight at study initiation: 1.9 - 2.4 kg
- Number of animals: 3 males, 3 females
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20.0 +/- 1 °C
- Humidity: 60 +/- 5 %
- Air changes: 15 times per hour
- Photoperiod: 12 hours artificial light, 12 hours dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- - Area of exposure: 6 cm2
- Total volume applied: 0.5 ml undiluted - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 24, 48, 72 hours
- Number of animals:
- 3 male, 3 female
- Details on study design:
- TEST SITE
- Area of exposure: 6 m²
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 72 hours
EXAMINATIONS
- Examination time points: 1, 24, 48, and 72 hours after patch removal
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not aplicable
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0
REVERSIBILITY: not applicable - Other effects:
- no other effects
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize Scores and according to EU Directive 67/548/EEC
- Conclusions:
- Classification: not irritating
- Executive summary:
The acute skin irritation properties of 2,2,4(or 2,4,4)-trimethyladiponitrile were tested according to OECD Guideline 404 (1981). A dose of 0.5 ml undiluted test item per animal was applied to the shorn, intact dorsal skin of 3 male and 3 female rabbits under occlusive conditions for 4 hours. After removal of the patches the treated skin areas were rinsed with water and dried. The results were assessed 1, 24, 48 and 72 hr after patch removal. Under the test conditions no significant irritancy to skin was observed, irritation index 0 of max. 8.0. Therefore, 2,2,4(or 2,4,4)-trimethyladiponitrile is not irritating to skin.
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