Registration Dossier
Registration Dossier
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EC number: 700-144-0 | CAS number: 13115-71-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-12-01 to 1992-12-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
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
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Comission Directive No. 84/449/EEC
- Version / remarks:
- adopted 25 April, 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2S)-2-(2-aminoacetamido)-4-carbamoylbutanoic acid
- EC Number:
- 700-144-0
- Cas Number:
- 13115-71-4
- Molecular formula:
- C7H13N3O4
- IUPAC Name:
- (2S)-2-(2-aminoacetamido)-4-carbamoylbutanoic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, Halle, Germany
- Age at study initiation: 8 - 12 months
- Weight at study initiation: 2.31 - 2.46 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
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.5
- Humidity (%): 55 - 70
- Photoperiod: 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g test item glycyl-L-glutamine monohydrate, equivalent to 0.46 g anhydrous glycyl-L-glutamine, moistened with 0.25 mL water
VEHICLE
- Amount(s) applied: 0.25 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left site of the vertebral column (dorsal skin area between shoulder and sacrum), 6.25 cm2
- Type of wrap if used: The site of application was covered with a patch consisting of two layers: a cellulose fabric coated with natural rubber and a synthetic film glue. A bandage wrapped several times around the trunk provided a complete occlusion.
REMOVAL OF TEST SUBSTANCE
- Washing: After the end of the exposure period remaining test material was gently washed off as far as possible.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system
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
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritant / corrosive response data:
- No local reactions indicative for skin irritation were observed at any time point in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test item is not irritating to the skin.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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