Registration Dossier
Registration Dossier
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EC number: 200-291-6 | CAS number: 56-84-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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
- Reference substance name:
- Aspartic acid
- EC Number:
- 200-291-6
- EC Name:
- Aspartic acid
- Cas Number:
- 56-84-8
- Molecular formula:
- C4H7NO4
- IUPAC Name:
- aspartic acid
- Reference substance name:
- L-Asparaginsäure
- IUPAC Name:
- L-Asparaginsäure
- Reference substance name:
- S-(+) amino succinic acid
- IUPAC Name:
- S-(+) amino succinic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Supplier: Sponsor.
Batch No.: PRCA 015.
CAS No. 56-84-8.
Appearance: White, crystalline.
Purity: Approx. 99 %.
pH: 2.5 – 3.5 (4 g/L at 20 °C). Determined for a 1 % w/v suspension: 3.03.
Melting range: 265 – 271 °C.
Solubility in water: 5 g/L at 25°C.
Conditions of storage: In the refrigerator, in the dark, may be used under light.
Date of expiry: 31 December 2002.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Supplier: Charles River Wiga, D-97633 Sulzfeld.Hygiene: Optimal hygienic conditions.
Weight: 1.8 to 2.0 kg at the start of the study.
Room temperature: Average of 19.1 °C (continuous control and recording).
Relative humidity: Average of 53.6 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in metal wire cages, 79 cm x 59 cm bottom area, 38 cm height, with a wooden rest shelf, 15 cm x 59 cm.
Feed Altromin 2023 diet for rabbits, ad libitum. Hay-briquetteswere offered additionally as a dietary supplement.
Water: Tap water from an automatic watering system, ad libitum.
Acclimatisation: 5 days.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- substance was moistened with 1 mL.
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The skins of the animals were examined for local alterations after the clipping procedure (one day before the application) and immediately before the application. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3 females.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: erythema as well as edema scores
- Basis:
- animal: No. 1, 2 and 3
- Time point:
- other: 1, 24, 48 and 72 hours after patch removal.
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
- Other effects:
- No general toxic effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- All exposed skin sites were normal at each examination term.
- Executive summary:
The possible irritating or corrosive effects of the substance, following a single application to the intact skin of rabbits, was investigated in conformance with the OECD-Guideline 404 and the Directive 92/69/EEC, method B.4.
All exposed skin sites were normal at each examination term.
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