Registration Dossier
Registration Dossier
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EC number: 306-797-4 | CAS number: 97404-33-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- June 23rd, 1987 - June 30th, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study, however lack of details on test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, isotridecyl esters
- EC Number:
- 306-084-8
- EC Name:
- Fatty acids, C16-18, isotridecyl esters
- Cas Number:
- 95912-88-2
- Molecular formula:
- C29H58O2 and C31H62O2
- Details on test material:
- - Name of test material (as cited in study report): Isotridecylstearat
- Physical state: colourless liquid
- Analytical purity: not reported
- Stability: not reported
Constituent 1
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: not reported
- Weight at study initiation: average weight: 2442 g
- Housing: single housing in rabbit-batteries, Fa. Heinkel, Kuchen, Germany.
- Diet (e.g. ad libitum): rabbit diet 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- % coverage: The test substance was applied onto a 2.5 cm x 2.5 cm sized piece of linen.
- Type of wrap if used: A plastic film covered the piece of linen. The plastic film was fixed with adhesive tapes and additionally an acrylastic band assured fixation and occlusive coverage of the treated site.
During the 4 -hour exposure the animals were kept in special boxes to avoid dislocation of the linen pieces.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
SCORING SYSTEM: 84/449/EWG, Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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