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Registration Dossier
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EC number: 234-717-7 | CAS number: 12027-06-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Skin irritation study of the test chemical
- Author:
- United Nations Environmental Programme (UNEP)
- Year:
- 2 003
- Bibliographic source:
- OECD HPV Chemicals Programme, SIDS Dossier, approved at SIAM 17 (11-14 November 2003)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register, vol.43, no 163-Tuesday, Aug.22, 1978
- Principles of method if other than guideline:
- To assess the dermal irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- Molecular formula:
- ClH4N
- IUPAC Name:
- Ammonium chloride
- Details on test material:
- - Name of the test chemical: Ammonium chloride
- Molecular formula : NH4Cl
- Molecular weight : 53.19 g/mol
- Substance type: Inorganic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Rich-Glo-farms (U.S.D.A. 74-AA-29), El Campo, Texas
- Housing: The animals were housed in galvanized steel cages placed over trays lined with aspen bedding.
- Diet: Purena Complete Rabbit Chow, Lot #197C , ad libitum
- Water: City of Houston Tap Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 - 76 degree F
- Humidity (%): Relative humidity from 40 to 60 %.
- Air changes (per hr): air conditioned rooms
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact, abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 gram of crystalline test chemical
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48, 72 and 96 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: intact and abraded back skin
- % coverage: double layered 1 square inch gauze pad
- Type of wrap if used: polyethylene wrapper was placed over the bandages and wound around the trunk. The wrapper was secured with masking tape.
SCORING SYSTEM: The skin reactions were scored according to the method of Draize.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Abraded(12tests) : Score(2)X7,(3)X5 /0 /0
Unabraded(12tests): Score(2)X7,(3)X5 /0 /0
The test chemical was moderately irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Redness was observed at all 7 sites on the abraded and intact skin of rabbits after 24 hours of exposure. Hence the test chemical was considered to be moderately irritating to skin.
- Executive summary:
The dermal irritation potential of the test chemical was assessed in rabbits according to Federal Register, vol.43, no 163-Tuesday, Aug.22, 1978 Guidelines. 6 New Zealand White rabbits were used for the study. The backs of 6 rabbits were clipped free of hair in an area of about 15 X 12 square cm. The backs of the animals were divided into quadrants. The animals were abraded in a 2 square mm cross-hatch pattern on the tattoo side by drawing a lancet across the skin, being careful not to penetrate the dermis. Two-one square inch areas on each rabbit were tested. Two unabraded additional 1 square inch sites on each rabbit were also tested. 0.5 gram of crystalline test chemical were placed in a double layered 1 square inch gauze pad and affixed to the four test sites on each animal with adhesive tape. The gauze was moistened with about 1 mL of distilled-deionized water and a polyethylene wrapper was placed over the bandages and wound around the trunk. The wrapper was secured with masking tape.The animals were placed in a restraining box and replaced in their individual cages. Water was available to the animals during the test. After 24 hours the animals were released from their restraints and the bandages were removed. All bandages were stuck to the skin by the test materials but peeled away with no skin removed. The remaining test materials was brushed of the skin but was not otherwise removed.The skin reactions were scored according to the method of Draize. Redness was observed at all 7 sites on the abraded and intact skin of rabbits after 24 hours of exposure. Hence the test chemical was considered to be moderately irritating to skin.
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