Registration Dossier
Registration Dossier
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EC number: 404-800-4 | CAS number: 118832-72-7 IRGANOX L 118
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-03-01 to 1988-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate
- EC Number:
- 404-800-4
- EC Name:
- Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate
- Cas Number:
- 118832-72-7
- Molecular formula:
- C30H52O3S
- IUPAC Name:
- 11-methyldodecyl 2-{[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]sulfanyl}acetate
- Details on test material:
- - Physical state: liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2110 to 2610g
- Housing: Individually in metal cages
- Diet: Standard rabbit pellet, Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral flank of each rabbit served as control (control gauze patch)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of the test item - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 7 days
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approx. 36 cm2 on flanks of the animals
- Type of wrap: the patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place by an adhesive tape (Isoplast)
SCORING SYSTEM: OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Minimal erythema was observed in one animal, reversible within 24 hours. The same animal also showed minimal signs of edema, reversible within 72 hours. The other two animals did not show any signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not irritant to the rabbit skin under the conditions of this study.
- Executive summary:
An acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of the test substance (described in section 1.2) on the albino rat skin. This test was based on the OECD Guideline No. 404 (Acute Dermal Irritation/ Corrosion) and was performed on 3 female rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 mL of the test article was applied to the flank of each animal and held in place for 4 hours by an adhesive tape. A control gauze patch was applied to the contralateral flank. Because slight reactions were observed within 72 hours after dermal application of the test article, the observation period was extended to 7 days to determine the reversibility of the skin reactions. Only minimal erythema was observed in one animal, reversible within 24 hours. The same animal also showed a minimal edema, reversible within 72 hours. The other two animals did not show any signs of irritation. Based on the study results, the test item was found to be not irritating to the rabbit skin.
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