Registration Dossier
Registration Dossier
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EC number: 618-251-5 | CAS number: 89182-60-5
Endpoint summary
Administrative data
Description of key information
Oral, subacute 4 weeks (Rat-Wistar, GLP, OECD TG 407): NOAEL = 1000 mg/kg
[Bayer AG, Report No. PH-34477, 2006-05-31]
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Feb-Mar 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- demineralized water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- once daily
- Remarks:
- Doses / Concentrations:
40, 200, 1000 mg/kg in an application volume of 10 ml/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed up to the highest dose
- Critical effects observed:
- not specified
- Executive summary:
N-Formylaminosorbit was administered daily via gavage in demineralized water to 5 male and 5 female Wistar rats per dose group, in doses of 0, 40, 200 and 1000 mg/kg body weight for a period of 4 weeks. The animals were regularly observed and weighed. Food intake was determined. FOB as well as MA/LMA tests and clinical laboratory investigations on blood samples were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed.
Survival was not affected by treatment and no adverse effects were detected up to and including the highest dose group.
Therefore, the NOAEL in male and female rats was established to be 1000 mg/kg body weight/day.
Reference
No animal died unscheduled within the study. Up to and including the highest dose group no clinical signs as well as no effects on body weight gain, food intake, hematology and clinical chemistry were observed. FOB and MA/LMA didnot indicate neurotoxicity up to 1000 mg/kg. Moreover, no substance-related adverse effects were detected on organ weights and at necropsy and histopathology.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a subacute oral toxicity study in rats N-Formylaminosorbit was administered daily via gavage in demineralized water to 5 male and 5 female Wistar rats per dose group, in doses of 0, 40, 200 and 1000 mg/kg body weight for a period of 4 weeks. The animals were regularly observed and weighed. Food intake was determined. FOB as well as MA/LMA tests and clinical laboratory investigations on blood samples were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed.
Survival was not affected by treatment and no adverse effects were detected up to and including the highest dose group.
Therefore, the NOAEL in male and female rats was established to be 1000 mg/kg body weight/day.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
only one study available
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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