Registration Dossier
Registration Dossier
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EC number: 214-029-3 | CAS number: 1073-69-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, no scoring of the skin irritation.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicity of hydroxylamine sulfate following dermal exposure: variability with exposure method and species.
- Author:
- Derelanko
- Year:
- 1 987
- Bibliographic source:
- Fundamental and applied toxicology, 8:583–594.
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 994
- Reference Type:
- secondary source
- Title:
- Concise International Assessment Document 19: Phenylhydrazine
- Author:
- WHO
- Year:
- 2 000
- Bibliographic source:
- Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, ISBN 92 4 153019 7; ISSN 1020-6167
Materials and methods
- Principles of method if other than guideline:
- Rabbits were exposed for 24 hours to a single topical application of test material. The test material was covered with either a porous gauze patch (semiocclusive) or a plastic cover (semiocclusive).
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Phenylhydrazine hydrochloride (PHZ)
- Physical state: no data
- Analytical purity: 97 %
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: individually in single unit, suspended steel cages
- Diet: Purina High Fiber Diet 5321, ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C
- Humidity (%): 50 %
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- other: semiocclusive or occlusive
- Preparation of test site:
- other: clipping
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 and 0.01 g/kg bw (the last one only with occlusive conditions);
- Concentration (if solution): Distilled water was used to moisten the test material for topical application. - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 14 days
- Number of animals:
- 10 females per dose; except 0.5 g/kg PHZ under gauze cover: 5 females were used.
- Details on study design:
- TEST SITE
- Area of exposure: back and flanks
- Type of wrap if used: The test material was covered with either a 10 x 10 cm porous gauze patch opened to cover a 10 x 20 cm area of skin or a plastic cover. The plastic cover consisted of either a 25-mm Hill Top Chamber from which the cotton swatch was removed or a medium-size disposable weighing boat, the depth of which was reduced by trimming off part of the wall. The weighing boat was used for dose levels of 0.5 g/kg or greater. Both the gauze and plastic covers were held in place with Blenderm surgical tape. The entire trunk of the animal was wrapped with Saran Wrap which was in turn held in place by a wrapping of athletic adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the wrappings, the exposure site was wiped with gauze soaked with distilled water to remove residual test material.
- Time after start of exposure: 24 hrs
Results and discussion
In vivo
Results
- Irritation parameter:
- other: irritation
- Basis:
- other: no data
- Time point:
- other: no data
- Score:
- > 0
- Reversibility:
- no data
- Remarks on result:
- other: The available data clearly indicates that the test substance is irritating to the skin although no scores have been provided.
- Irritant / corrosive response data:
- see remarks on results
- Other effects:
- no data
Any other information on results incl. tables
Results for the study are only available in descriptive form. Skin irritation with some necrosis at the exposure site was observed 24 hr postapplication of the test material. Necrosis appeared more severe when the chemical was applied under plastic than when gauze was used. Sloughing of the skin eventually occurred at the higher dose level.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
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