Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across to related substance with same EC number (410-190-0) identified during Inquiry Process (Inquiry number: 06-0000021779-56-0000). Previous data (>12 yrs old) provided by ECHA.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test Duration: 28 days
- Frequency of treatment:
- Dosing regime: 5 days / week
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 125 mg/kg bw/day
Male: 10 animals at 500 mg/kg bw/day
Male: 10 animals at 2000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 125 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day
Female: 10 animals at 2000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- not examined
- Dermal irritation:
- not specified
- Mortality:
- not examined
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical observations:
No deaths and no signs of toxicity were observed.
Laboratory findings:
A slightly increased (33%) level of aspartate aminotransferase was seen in the 2000mg/kg treated females after four weeks.
Effects in organs:
Minimal epidermal hyperplasia was observed in females treated at 500 and 2000mg/kg.
Minor adrenal vacuolation was noted in 3 males at 2000mg/kg.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- 125 mg/kg bw/day
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Not classified for repeat dose dermal toxicity; the NOAEL was set to 500 mg/kg bw/d in this subacute dermal toxicity study.
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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