Registration Dossier
Registration Dossier
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EC number: 500-199-9 | CAS number: 68183-39-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study has been performed before GLP guidelines and OECD guidelines were in place for industrial chemicals. The study has been performed in a lab experienced to work under GLP for pharmaceuticals. The test method is similar to the later used OECD guideline method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S. Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- not specified
- Details on test material:
- - Substance type: organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: individual metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 14 / 10
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Both flanks were shaved. One flank was left shaved, the other was additionally abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g applied on a patch of 2.5x2.5 cm2 - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: impermeable material
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize score for erythema, edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 1.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 1.45
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: intact skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: intact skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not requiring classification Criteria used for interpretation of results: EU
- Conclusions:
- The test material applied to the skin is slightly irritant. Irritation disappears until 72 hours.
- Executive summary:
The test material applied to the skin is slightly irritant. Irritation disappears until 72 hours.
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