Solsperse 22000-Wirksubstanz

Toxicity to reproduction

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:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]

Principles of method if other than guideline:

EEC Directive 87/302/EEC, Annex V of the EEC Directive67/548/EEC, Part B: Methods for determination of Toxicology "One-Generation Reproductive Toxicity Test". Official Journal of the European Communities No. L 133, May 1988.OECD "Guidelines for Testing of Chemicals", Section 4,Health Effects, No. 415, "One-Generation Reproductive Toxicity Test", Paris Cedex, September 1983.

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on exposure:

Method of administration or exposure: Gavage

Frequency of treatment:

Dosing regime (males): 7 days/weekDosing regime (females): 7 days/week

Details on study schedule:

Number of litters per dose/conc.: 24 at mg/kg or mg/l

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

50 mg/kg bw/day (actual dose received)

Doses / concentrations 2

Dose / conc.:

200 mg/kg bw/day (actual dose received)

Doses / concentrations 3

Dose / conc.:

1 000 mg/kg bw/day (actual dose received)

Doses / concentrations 4

Dose / conc.:

0 mg/kg bw/day (actual dose received)

Remarks:

Control

No. of animals per sex per dose:

Male: 24 animals at 0 mg/kg or mg/lMale: 24 animals at 50 mg/kg or mg/lMale: 24 animals at 200 mg/kg or mg/lMale: 24 animals at 1000 mg/kg or mg/lFemale: 24 animals at 0 mg/kg or mg/lFemale: 24 animals at 50 mg/kg or mg/lFemale: 24 animals at 200 mg/kg or mg/lFemale: 24 animals at 1000 mg/kg or mg/l

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Dermal irritation (if dermal study):

not examined

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not specified

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

no effects observed

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not examined

Reproductive performance:

no effects observed

Details on results (P0)

Adults males and females tolerated the test substance at oral doses levels up to and including 1000 mg/kg/day without changes to appearance and behaviour and without effect on survival, body weight and food intake.The results of the study indicate that mating was successful in all groups with similar mean coital times recorded for all groups. There was no indication of any treatment related effects on fertility since fertility and conception rateswerer similat for treated and control groups. Gestation times were unaffected by treatment.

Effect levels (P0)

Key result

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Remarks on result:

not determinable due to absence of adverse toxic effects

Results: F1 generation

General toxicity (F1)

Clinical signs:

no effects observed

Dermal irritation (if dermal study):

not examined

Mortality / viability:

not specified

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not specified

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Sexual maturation:

no effects observed

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

no effects observed

Histopathological findings:

not specified

Other effects:

no effects observed

Developmental neurotoxicity (F1)

Behaviour (functional findings):

not examined

Developmental immunotoxicity (F1)

Developmental immunotoxicity:

not examined

Details on results (F1)

Effects on F1 generation:The viability of the pups was not influenced by treatment. Development of pups from treated dams progressed in a similar manner to those pups from control dams i.e. no treatment related clinical signs were observed and body weight development was similat for treated and control litters. Macroscopic examination of the pups at necropsy did not detect any lesions that were associated with exposure of the parents to the test substance.

Effect levels (F1)

Key result

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

> 1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Remarks on result:

not determinable due to absence of adverse toxic effects

Overall reproductive toxicity

Key result

Reproductive effects observed:

no

Lowest effective dose / conc.:

1 000 mg/kg bw/day (actual dose received)

Treatment related:

no

Applicant's summary and conclusion

Conclusions:

Based on the findings in the study, the no adverse effect level (NOAEL) for parental and developmental toxicity was established as more than 1000 mg/kg/day.

Executive summary:

Parental Data:

Adult males and females tolerated Hypersol Synergist L4722 at oral doses levels up to and including 1000 mg/kg/day without changes to appearance and behaviour, and without effect on survival, body weight or food intake.

There were no treatment-related macroscopic or microscopic lesions detected in parental animals.

Reproduction and litter data:

The result of the study indicate that mating was successful in all groups with similar mean coital times recorded for all groups. there was no indication of any treatment-related effects on fertility, since fertility and conception rates were similar for treated and control groups. Gestation times were unaffected by treatment.

The viability of the pups was not influenced by treatment. Development of pups from treated dams progressed in a similar manner to those pups from control dams i.e. no treatment-related clinical signs were observed and body weight development was similar for treated and control litters. Macroscopic examinations of the pups at necropsy did not detect any lesions that were associated with exposure of the parents to Hypersol Synergist L4722.

Based on the findings in the study, the no adverse effect level (NOAEL) for parental and developmental toxicity was established as more than 1000 mg/kg/day.