Registration Dossier
Registration Dossier
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EC number: 434-050-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-10 to 2002-04-22
- 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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- purity and stability of test item not given; 60 minute observation was missing; information on strain was missing
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2001-08-22
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation:
yellow green powder
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, cool and dark room
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Zimmermann, Schweizer Hof, D-73453 Untergröningen/Aalen, Germany
- Weight at administration day: 2650 to 3135 g
- Housing: housed individually in zinc wire cages (surface: 2450 cm², height: 42 cm) without bedding material
- Diet (ad libitum): Raiffeisen Ringfutter Kaninchen, Trockenfutter 52/P Raiffeisen, Kraftfutter Kehl
- Water (ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 -23°C
- Relative humidity: 30 -70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of test material moistened with the vehicle - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk was shaved (area: 3 x 5 cm²) and the test material was applied. The test area was covered with a patch (area: 6 cm) that was fixed with occlusive dressing. The dressing was fixed with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was washed with 0.9 % NaCl solution
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS :
Days 1, 2, 3, 4, 5, and 7
SCORING SYSTEM: according to the Draize scale
EXAMINATIONS:
Mortality, clinical signs, behaviour, body weight, and skin reactions
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation was observed throughout the study.
- Other effects:
- - no mortality was observed.
- no clinical signs were observed during the observation period.
- behaviour was calm and alert. It did not differ from rabbits, which were not involved in the study.
- rabbits gained body weight throughout the observation period, except for one male rabbits which lost weight on observation day 1. Afterwards, the male rabbit also gained throught the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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