Registration Dossier
Registration Dossier
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EC number: 475-290-9 | CAS number: 39537-23-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-04-02 to 1990-04-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- occlusive dressing
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- yes
- Remarks:
- occlusive dressing
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 475-290-9
- EC Name:
- -
- Cas Number:
- 39537-23-0
- Molecular formula:
- C8H15N3O4
- IUPAC Name:
- (2R)-2-[(2S)-2-aminopropanamido]-4-carbamoylbutanoic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld, Germany
- Age at study initiation: 9 - 10 months
- Weight at study initiation: 2.30 - 2.54 kg
- Housing: individually in stainless steel cages with grating floor
- Diet: standard Diet ssniff K ("special diet for rabbits") approx. 120 g/day/animal
- Water: drinking water, ad libitum
- Acclimation period: 1 day under test conditions before application of the product
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24.4
- Humidity (%): 30 - 50
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 1.6 mL demineralized water
VEHICLE
- Amount(s) applied: 1.6 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: applied on the shorn dorsal skin area between shoulder and sacrum (approx. 6.25 cm²)
REMOVAL OF TEST SUBSTANCE
- Washing: yes, after the end of the exposure time remaining test material was gently washed off
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- None of the three rabbits exposed for 4 h to 500 mg test substance/patch and animal (occlusive condition) showed any substance-related changes at the reading time points 60 min, 24, 48 and 72 h.
- Other effects:
- No systemic effects occurred after dermal appliation of the test substance. The general condition of the test animals was not affected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin reactions occurred in any animal at any observation point; erythema score and edema score: each 0 (mean of all animals, 24/48/72 h).
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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