Registration Dossier
Registration Dossier
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EC number: 606-826-3 | CAS number: 217308-07-1
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 and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)-
- EC Number:
- 606-826-3
- Cas Number:
- 217308-07-1
- Molecular formula:
- C8 H8 O3 .H3 N
- IUPAC Name:
- Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)-
- Details on test material:
- Name of the test substance used in the study report: (R)-Ammoniummandelat-Loesung (ca. 30%)
The test substance is an aqueous solution. The content of Ammoniummandelat was found to be 30% (29.1 - 31.2 g/1 00 g) and the content of water was found to be 70%.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Acclimatization period: At least 5 days before the beginning of the study.
ldentification of the animals: Ear tattoo
Age at the beginning of the study: About 8 months
Body weight range at the beginning of the study: 3.55 - 3.82 kg
The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2.
Type of diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 9/animal per day)
Watering: Tap water ad libitum
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:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- Clipping of the fur: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animals.
Application area: 2.5 x 2.5 cm
Application site: Upper third of the back or flanks
Readings: About 1 h, 24 h, 48 h and 72 h and 7 days after removal of the test patch.
The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1 : 1).
Body weight determination just before application of the test substance.
Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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