Registration Dossier
Registration Dossier
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EC number: 639-656-3 | CAS number: 8016-26-0
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- not specified
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- not specified
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a sub-chronic toxicity study (90 days) by the oral route does not need to be conducted because an appropriate dermal study is available and dermal is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
[Specific explanation in addition to field 'Justification for data waiving']
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Toxicity to aquatic algae and cyanobacteria
- Author:
- Ref 7.1.3
- Year:
- 2 007
- Bibliographic source:
- Toxicity to aquatic algae and cyanobacteria
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 958872-63-4
- Cas Number:
- 958872-63-4
- IUPAC Name:
- 958872-63-4
Constituent 1
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- 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
- Urinalysis findings:
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, non-treatment-related
Effect levels
- Dose descriptor:
- dose level: DL50
- Effect level:
- < 8 980 mg/kg bw/day (nominal)
- Basis for effect level:
- dermal irritation
Target system / organ toxicity
- Critical effects observed:
- no
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.
