Registration Dossier
Registration Dossier
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EC number: 418-570-8 | CAS number: 25383-07-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information from migrated NONS file, as per inquiry, data no longer protected
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized water
- Remarks:
- Doses / Concentrations:
0, 50, 100 and 200 mg/kg/day
Basis:
actual ingested - No. of animals per sex per dose:
- 28
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Reproductive effects observed:
- not specified
- Conclusions:
- The NOEL in one-generation reproduction toxicity study in female rats by oral route was 50 mg/kg/day both for mother and offspring (F0 and F1).
The NOAEL in one-generation reproduction toxicity study in female rats by oral route was 100 mg/kg/day both for mother and offspring (F0 and F1).
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The NOEL in one-generation reproduction toxicity study in female rats by oral route was 50 mg/kg/day both for mother and offspring (F0 and F1).
The NOAEL in one-generation reproduction toxicity study in female rats by oral route was 100 mg/kg/day both for mother and offspring (F0 and F1).
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The NOEL in one-generation reproduction toxicity study in female rats by oral route was 50 mg/kg/day both for mother and offspring (F0 and F1).
The NOAEL in one-generation reproduction toxicity study in female rats by oral route was 100 mg/kg/day both for mother and offspring (F0 and F1).
Justification for classification or non-classification
According to the results of the one-generation study performed with rats by oral route, and according to Regulation (EC) n. 1272/2008, Phenethylammonium salt of fosfomycin is classified as Repro. 2, H361.
Additional information
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