Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-323-3 | CAS number: 908020-52-0
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:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Kannami Laboratory, Bozo Research Center Inc
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory animals inc
- Age at study initiation: 17 or 18 weeks
- Weight at study initiation: 3.16 - 3.59 kg
- Housing: Aluminium cages (Nihon Cage Co Ltd) with wire mesh bottoms
- Diet (e.g. ad libitum): Free access to RC4 pelleted dies
- Water (e.g. ad libitum): Free access to tap water (Fujimi Water Union) via automatic water supply system
- Acclimation period: 12 - 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24°C
- Humidity (%): 50 - 76%
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 3 minutes to 4 hours
- Observation period:
- up to 6 days
- Number of animals:
- 3
- Details on study design:
- In this study 0.5 g of the test substance was applied to a lint sheet (2.5 x 2.5 cm) and moistened by 0.5 ml of water for injection and then it was applied to the clipped dorsal skin of rabbits for 3 minutes, 1 hour or 4 hours. Animals were observed periodically for dermal reactions including the corrosion reactions according to the Draize method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 1101, 1102 and 1103
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal: 1101, 1102 and 1103
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed through observation period
- Other effects:
- None observed.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
