Registration Dossier
Registration Dossier
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EC number: 939-682-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. Karl Thomae GmbH, 88400 Biberach; SPF-breeding
- Age at study initiation: 3-5months
- Weight at study initiation: 2.0 - 2.2 kg
- Housing:individually
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits, Altromin GmbH, Lage/LIppe, ad libitum; additionally 15 g hay/day
- Water (e.g. ad libitum): tap water from automatic devices, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 30 % active - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the body
- Type of wrap if used: adhesive patch with 2.5 x 2.5 cm cellulose padding (custom-made by Fa. Beiersdorf AG, Hamburg)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Dry, rough skin surface after 72 hours, coarse scales after 72 hours and 7 days, desquamation after 7 days, reversible by day 14
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Dry, rough skin surface after 72 hours, fine scales and desquamation after 7 days, reversible by day 14
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Dry, rough skin surface after 72 hours, fine scales and desquamation after 7 and 14 days
- Irritant / corrosive response data:
- After removal of the dressing the animals showed very slight to slight edema between 30 minutes and 72 hours, and very slight to moderate erythema up to day 7. The skin surface was dry, rough and showed fine to coarse scales, with desquamation. The irritation effects were fully reversible within 14 days.
Any other information on results incl. tables
According to the criteria of Directive 67/548/EEC and the criteria of Regulation (EC) No 1272/2008 the test substance at a concentration of 30% active has to be classified as irritating to the skin (R38, CLP Skin Irrit. 2).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- CLP: Skin irrit. 2, H315
DSD: Xi, R38
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