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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Inquiry result from ECHA
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD BR

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: diet
Details on exposure:
Method of administration or exposure: incorporation into the diet
Frequency of treatment:
Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week
No. of animals per sex per dose:
Male: 30 animals at 0 mg/kg or mg/l
Male: 30 animals at 63 mg/kg or mg/l
Male: 30 animals at 284 mg/kg or mg/l
Male: 30 animals at 1280 mg/kg or mg/l
Female: 30 animals at 0 mg/kg or mg/l
Female: 30 animals at 86 mg/kg or mg/l
Female: 30 animals at 388 mg/kg or mg/l
Female: 30 animals at 1727 mg/kg or mg/l

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

The only sign of toxicity related to treatment was soft and/or irregularfaeces observed in 24/30 males during the post mating period, i.e. after 11 weeks treatment, and in females only during the premating period beginning after 6-7 dosing. No treatment related effects on fertility were observed. On the basis of these results the NOAEL for general toxicity is considered to be 284 mg/kg/day for males and 388 mg/kg/day for females and that for fertility is 1280 mg/kg/day for males and 1727 mg/kg/day for females.

Results: F1 generation

Details on results (F1)

Effects on F1 generation: No treatment-related effects were seen at any dose level.
The NOAEL for developmental effects is therefore considered to be 1727 mg/kg/day.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Refer to the overall remarks, attachment section

Applicant's summary and conclusion