Registration Dossier
Registration Dossier
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EC number: 258-556-7 | CAS number: 53445-37-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-12-17 to 1986-01-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
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)-trimethyladipic acid
- EC Number:
- 258-556-7
- EC Name:
- 2,2,4(or 2,4,4)-trimethyladipic acid
- Cas Number:
- 53445-37-7
- Molecular formula:
- C9H16O4
- IUPAC Name:
- 2,2,4-trimethylhexanedioic acid; 2,4,4-trimethylhexanedioic acid
- Details on test material:
- 2,2,4(or 2,4,4)-Trimethylhexanedioic acid of Hüls AG, purity 87 %, impurities methylpentanedoic acid and methylbutanedioic acid not quantified
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: 2.1 - 2.6 kg
- Number of animals: 3 males, 3 females
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tab water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 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:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- - Examination time points: 1, 24, 48, 72 hours, 6, 8, 11, and 14 days after patch removal; evaluation based on readings 1-4
- Number of animals:
- 6
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: warming (melting) and mixing
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml (approximately 30 °C)
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 14 days
EXAMINATION
- 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 hours
- Score:
- 1.09
- Max. score:
- 8
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: some crust in 1 male on days 6 and 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.67
- Edema: 0.22
REVERSIBILITY: complete within 11 days; some crust in 1 male on days 6 and 8 - Other effects:
- no other effects
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize Scores and according to EU Directive 67/548/EEC
- Conclusions:
- According to the study, the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid showed slightly irritant effect on the skin of male and female rabbits.
- Executive summary:
The acute skin irritation properties of 2,2,4(or 2,4,4)-trimethylhexanedioic acid were determined 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. According to the study, the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid showed slightly irritant effect on the skin of male and female rabbits.
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