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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
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).
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