Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to an official guideline. Only basic data is shown on the ECHA webpage.

Data source

Reference
Reference Type:
other: ECHA disseminated dossier
Title:
No information
Report Date:
2014

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

open allclose all
Dose descriptor:
other: NOAEL (fertility)
Effect level:
450 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: No treatment related reproductive effects were obseved in this study.
Remarks on result:
other: Generation: F0 and F1 (parental) (migrated information)
Dose descriptor:
other: NOAEL (offspring)
Effect level:
175 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: F1 (males) significantly reduced body weights at 450 mg/kg bw group F2: Significantly reduced lactation index in the 450 mg/kg bw group
Remarks on result:
other: Generation: F1 and F2 (migrated information)
Dose descriptor:
other: NOAEL (general toxicity)
Sex:
male/female
Basis for effect level:
other: 450 mg/kg bw: increased mortaliity; 450 and 175 mg/kg bw/d: Signs of intoxication
Remarks on result:
not measured/tested
Remarks:
Effect level not specified Generation: F0 and F1 (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

F0-genration:
---Mortality during pre-breed period:
450 mg/kg bw/d males: 12/25 and females: 8/25
---Signs of intoxication.
450 mg/kg bw/d, males and females:
hypoactivity, ataxia, twitches, tremors, prostration, gasping, rapid respiration, lacrimation, amd perioral wetness occurred immediately after dosing but did not persist until the next day.
---Mean weight gain in F0 males and F0 females were equivalent across the groups
---Mean body weight, significantly reduced:
males: 175 mg-gr., 450 mg-gr., week 13: 489.9 g,470.9 g versus 522 g of controls

---Reproductive parameters for F0 parents at F1 breed:
Mating index (males and females), fertility index (males and females) and gestational index were not affected by treatment.
--Body weight development during gestation and lactation was equivalent across the groups.
--F1-pups:
-Live-birth index was comparable across the groups, sex ratio was not affected
-Survival Indices:
4-day-, 7-day-, 14-day- and 21-day-survival indices and lactation index were equivalent across the groups.
450 mg/kg bw/d,males (pre-breed period): significantly reduced mean body weights: 139.6 g versus 162 g in controls
F1-adult-generation
---Signs of intoxication.
450 mg/kg bw/d, males and females:
hypoactivity, ataxia, twitches, tremors, prostration, gasping, rapid respiration, lacrimation, and perioral wetness
175 mg/kg bw/d:
males: perioral wetness
females: hypoactivity, ataxia, perioral wetness
---Mortality
450 mg-group:
pre-breed period: 8 males and 14 females
additionally:
7 males and 9 females died prior to mating, 3 females which were found pregnant died and another one died during gestation
---body weight and weight development
females: equivalent across the groups
males: week 14, low, mid, high dose: 586.6 g, 564.1 g, 494.4 g versus 526.3 g of controls
---Reproductive parameters for F1 parents at F2 breed:
Mating index (males and females), fertility index (males and females) and gestational index were not affected by treatment.
--Body weight development during gestation and lactation was equivalent across the groups.
--F2-pups:
-Live-birth index was comparable across the groups, sex ratio was not affected
-Survival Indices:
4-day-, 7-day-, 14-day- and 21-day-survival indices were equivalent across the groups.
lactation index
450 mg-group: was significantly reduced (75.5 versus 99.4 in controls)



Applicant's summary and conclusion