Registration Dossier
Registration Dossier
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EC number: 227-842-3 | CAS number: 6000-44-8
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:
- guideline study
- Justification for type of information:
- See read across document in section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- β-alanine
- EC Number:
- 203-536-5
- EC Name:
- β-alanine
- Cas Number:
- 107-95-9
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- beta-alanine
Constituent 1
- Specific details on test material used for the study:
- Sponsor's identification: β-Alanine
Description : white crystalline solid
Batch number : 102657
Date received : 20 April 2010
Expiry date : 20 April 2013
Storage conditions: room temperature in the dark over silica gel
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals and Animal Husbandry
Two New Zealand White rabbits were supplied by Harlan Laboratories U.K. Ltd., Loughborough, UK. At the start of the study the animals weighed 2.09 or 2.16 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminantof a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: test material moistened with distilled water
- Amount / concentration applied:
- 0.5g of test material moistened with 0.5mL of distilled water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2
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: No evidence of skin irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of irritation
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not irritating
- Conclusions:
- The test material produced is not irritanting to the skin of the rabbit according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
A single 4-Hour, semi-occluded application of the test material to the intact skin of two rabbits produced no evidence of skin irritation.
The test material produced is not irritanting to the skin of the rabbit according to the Draize classification scheme. No corrosive effects were noted.
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