Registration Dossier
Registration Dossier
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EC number: 925-045-1 | CAS number: 1184842-87-2
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:
- other: GLP compliant guideline study, available as unpublished report. No restrictions, fully adequate for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- other: Amendment
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1184842-87-2
- Cas Number:
- 1184842-87-2
- IUPAC Name:
- 1184842-87-2
- Details on test material:
- - Name of test material (as cited in study report): Asta-C9-Diol-Natrium
- Physical state/appearance: Liquid, red-brown
- Storage conditions: Refrigerator, exclusion of light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.70 - 2.98 kg
- Housing: Single housing in stainless steel wire mesh cages with grating. Floor area: 3000 cm2. No bedding in the cages.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland. About 130 g per animal per day
- Water: Tap water, about 250 mL per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12 ( 6.00 a.m. - 6.00p.m. / 6.00 p.m. - 6.00 a.m.)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin of the same animal
- Amount / concentration applied:
- The test patches (2.5 x 2.5 cm) were moistened with 0.5 mL of the unchanged liquid test substance
- Duration of treatment / exposure:
- 4 hour
- Observation period:
- 72 hour
- Number of animals:
- 3 (1 male and 2 female animals)
- Details on study design:
- - Application site: upper third of the back or flanks
- Readings: 1 h, 24 h, 48 h and 72 h after removal of the test patches
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hour
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test the substance is considered to be not irritating to the skin.
- Executive summary:
The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (in compliance with GLP) by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semi-occlusive dressing. The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours after removal. No skin reaction could be observed at any time point; thus the study was terminated 72 hours after removal of the dressings. It was concluded that the test substance was not irritating to the skin.
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