Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- Occlusive treatment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 2002)
- Deviations:
- yes
- Remarks:
- Occlusive treatment. Treatment of 4 animals. No data on purity of test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult
- Sex: male
- Weight at study initiation: 2.31 kg (mean)
- Housing: single housing
- Diet: Diet 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch with test substance, covered with a plastic film and fixed with adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing: no data
SCORING SYSTEM:
Draize scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Calculated from the raw data.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Calculated from the raw data.
Any other information on results incl. tables
In the original assessment of the study a primary irritation index of 0.5 based on readings after 24, 48, and 72 hours was reported. (PII = Sum of all reactions/(Number of animals*Number of reading time points)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, the test substance showed no skin irritating potential
- Executive summary:
In a study according to OECD TG 404 (adopted 1981, GLP), the skin irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. The rabbits were treated with 0.5 mL of the undiluted test substance for 4 hours under occlusive conditions. Readings were performed 1, 24, 48, and 72 hours after application. An erythema mean score of 0.5 was calculated from the results after 24, 48, and 72 hours. The findings were fully reversible within 72 h. The corresponding edema score was 0. In conclusion, the test substance showed no skin irritating potential
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