Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study cited by Messinger et al., 2007.

Data source

Reference
Reference Type:
review article or handbook
Title:
Investigations on the effects of alkyl polyglucosides on development and fertility
Author:
Messinger H, Aulmann W, Kleber M and Koehl W
Year:
2007
Bibliographic source:
Food and Chemical Toxicology, 45, 1375-1382

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
Room temperature and relative humidity are maintained at 21 ± 2 C and 55% ± 10%, respectively. There are approximately 15–20 air changes per hour. The rooms are lit by artificial light for 12 h each day. The animals have ad libitum access to water and a commercially available laboratory rodent diet.
Details on mating procedure:
Matings are monogamous.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
Dose volumes are calculated according to individual body weight on the first day of treatment and adjusted for body weight at weekly intervals.
Duration of treatment / exposure:
Treatment by gavage begins 7 days after allocation for both males and females. Treatment commenced when males and females are approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum).
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
300 mg/kg bw/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1000 mg/kg bw/day
Basis:
nominal conc.
No. of animals per sex per dose:
10 animals per dose-group.
Control animals:
yes

Examinations

Parental animals: Observations and examinations:
Clinical signs, food consumption and body weight gain
Oestrous cyclicity (parental animals):
Effects related to reproduction and hormone balance such as estrous cycle, mating performance, pregnancy rates and the number of embryo resorptions are registered. Vaginal smears are taken daily for 14 days prior to pairing and each morning during the pairing period to detect marked anomalies of the oestrous cycle and to determine the median pre-coital interval.
Litter observations:
Clinical signs, food consumption and body weight gain
Postmortem examinations (offspring):
Pup losses are recorded and the filial generation is examined for behavioural abnormalities and external growth abnormalities.
Reproductive indices:
Copulatory indices, pregnancy rates, fertility indices and copulatory intervals are determined.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed

Details on results (P0)

No adverse effects were observed regarding male and female reproductive organs, even at the very high dose of 1000 mg/kg bw/day.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings:
not specified

Details on results (F1)

Clinical signs do not show treatment related effects on pre-weaning pups nor do necropsy reveal any effects in decedent or Fl pups. There is no difference between treated and control animals as assessed by macroscopic examination.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.
Executive summary:

Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.