Registration Dossier
Registration Dossier
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EC number: 404-110-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 04 Apr 1989 to 07 Apr 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 404), according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 12 May 1981)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (Commission Directive 84/449/EEC, adopted 25 April 1984)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.8-2.2 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay (about 15g/day)
- Water: deionised, chlorinated water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.65 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours after end of exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Baiersdorf)
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3
- Time point:
- other: 24, 48, and 72 hrs after end of exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: slight erythema (score 1) in all animals one hour after end of exposure but not at later time points
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3
- Time point:
- other: 24, 48, and 72 hrs after end of exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable since no edema was visible at any time point
- Irritant / corrosive response data:
- Very slight erythema (score 1) occurred one hour after path removal. The skin of all animals was couloured purple at this time point.
Twenty four hours after end of exposure none of the animals showed any irritation reaction. The skin of one animal was coloured till 24 h after end of exposure. The skin of another animal was coloured till the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not irritating to skin under the conditions of the test.
- Executive summary:
The test item was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404 (adopted 12 May 1981) and GLP. Animals were treated with 500 mg of the test item (pasted with polyethylene glycol 400) for 4 h under semiocclusive conditions. Slight erythema (score 1) were observed in all three animals one hour after end of exposure, but not at later time points (mean score for the 24, 48, and 72 hrs reading: 0). No edema were observed at any time points. The skin of all animals was couloured purple one hour after end of exposure. Skin colouration retained in one animal till 24 hours after end of exposure and in another animal till 72 hours after end of exposure. The test item was not irritating to skin under the conditions of this test.
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