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Registration Dossier
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EC number: 405-490-3 | CAS number: 613-62-7 BENZYL-2-NAPHTHYLETHER; BETA-NAPHTHYLBENZYLETHER (BON); BNE; BON; NIPAFAX BNE; SENSLON-50; ZO-1
Endpoint summary
Administrative data
Description of key information
For the oral and dermal route, acute toxicity studies are available. These studies were designed as limit dose studies and no toxicity was noted.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study used for notification under 67/548. Original study report not available.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- no data
- Doses:
- no data
- No. of animals per sex per dose:
- 5
- Details on study design:
- no data
- Statistics:
- no data
- Preliminary study:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- no mortality occured
- Clinical signs:
- other: Signs of toxicity related to dose levels: after application tousled fur was observed for the rest of the day. no other signs of toxicity were observed throughout the study.
- Gross pathology:
- no gross lessions were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The limit test for oral toxicity in the rat did not show any toxic effects up to a dose of 5000 mg/kg bw.
- Executive summary:
The study was conducted according to Guideline EU B.1 and was designed as a limit test.
A single dose of 5000 mg/kg bw of the substance in CMC (carboxymethyl cellulose) was administered to rats by the oral route.
After the application, the animals showed tousled fur for the rest of the day. No signs of toxicity were observed for the duration of the study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- one study available
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study used for notification under 67/548. Original study report not available.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- no data
- Duration of exposure:
- 24 h
- Doses:
- no data
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- no data
- Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- mortality was not observed during the study period
- Clinical signs:
- other: no signs of toxicity observed.
- Gross pathology:
- no gross lessions were observed.
- Other findings:
- Signs of toxicity (local):
no signs of dermal toxicology at application sites observed. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The limit test for dermal toxicity in the rat did not show any toxic effects up to a dose of 2000 mg/kg bw.
- Executive summary:
The study was conducted according to Guideline EU B.3 and was designed as a limit test.
A single dose of 2000 mg/kg bw of the substance was administered to rats by the dermal route.
No signs of toxicity were observed for the duration of the study
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- one study available
Additional information
One study available, used for former regulatory purposes.
Justification for selection of acute toxicity – dermal endpoint
One study available, used for former regulatory purposes.
Justification for classification or non-classification
The study results are conclusive but not sufficient for classification.
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