Registration Dossier
Registration Dossier
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EC number: 931-210-9 | CAS number: 1266534-73-9
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: see 'Remark'
- Remarks:
- Meets generally accepted scientific principles. The main restriction for assigning a reliability of (2) is that the substance was applied under occlusive conditions for 24 hours instead of semi-occlusively for 4 hours (cf. OECD TG 404 as compared to OECD TG 402).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: guidelines of the Federal Hazardous Substance Labeling Act
- GLP compliance:
- no
Test material
- Reference substance name:
- 930-915-9
- EC Number:
- 930-915-9
- IUPAC Name:
- 930-915-9
- Details on test material:
- - Name of test material (as cited in study report): Code 504 Can #19a
- Related CAS number: 1318-02-1
- Physical state: white fine powder
- Analytical purity: no data
- surface modified with approx. 10% rare earth elements
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 2000 mg/kg
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h
- Number of animals:
- 5
- Details on study design:
- After a 7-day acclimation period, ten rabbits were clipped free of fur over the entire upper back area. Five of the test sites were abraded by making a series of five parallel superficial scratches in the dermis; the remaining five were left intact. The compound was applied at 2000 mg/kg of bw to the shaved skin and wrapped with an impervious band which was left in place for 24 hours. Animals were observed for mortality and for signs of erythema or edema according to the Draize scoring system for up to 48 hours. Body weight was recorded at dosing.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 5 animals
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Irritant / corrosive response data:
- No deaths were noted up to 48 hours after application. Neither erythema nor edema were observed at any rabbit after 24 and 48 hours, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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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