Registration Dossier
Registration Dossier
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EC number: 500-281-4 | CAS number: 98362-33-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-11-23 to 1985-12-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Guideline study; in deviation from OECD TG 404 occlusive dressing was used.
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:
- yes
- Remarks:
- occlusive dressing
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
- EC Number:
- 500-281-4
- EC Name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
- Cas Number:
- 98362-33-5
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and 4-methylbenzenesulfonic acid
- Test material form:
- liquid: viscous
- Details on test material:
- Yellowish liquid, high viscosity
Content: 100%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- - Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.7 kg - Environmental conditions:
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
Air change: 15 times/hour;
Light: 12 hour light/dark rhythm;
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
water: tap water ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL test item
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- - Post exposure observation period: 8 days
- Observations at 1, 24, 48, 72 hours, 6, 9, 12 and 14 days after administration of the test substance - Number of animals:
- 3 males, 3 females
- Details on study design:
- - Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing for 4 hours
- Removal of test substance: washing with warm water
- Scoring system: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1; 24; 48; 72 h
- Score:
- 1.67
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0.39
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.33
- Edema: 0.39
- Irritation index: 1.67/8 - Other effects:
- no further information
Any other information on results incl. tables
To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales. For details see attached table.
Applicant's summary and conclusion
- Conclusions:
- According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.
- Executive summary:
To test the acute skin irritant effect of the test item
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.
To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales.
According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.
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