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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Investigations on the effects of alkylpolyglucosides on development and fertility
Author:
H. Messinger, W. Aulmann, M. Kleber, W. Koehl
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) 1375-1382

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Version / remarks:
27th July 1995
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alkylpolyglucosides C12-14 fatty alcohol
IUPAC Name:
Alkylpolyglucosides C12-14 fatty alcohol
Test material form:
not specified
Specific details on test material used for the study:
Limited details on test substance might also be described as D-Glucopyranose, Oligomeric, C10-16 Alkyl Glycosides

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no information
- Age at study initiation: no information
- Weight at study initiation: no information
- Fasting period before study: no information
- Housing: 5 animals per sex per cage
- Diet: ad libitum (commercially available laboratory rodent diet)
- Water: ad libitum
- Acclimation period: no information
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C (+/- 2°C)
- Humidity: 55 % (+/-10 %)
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on mating procedure:
- M/F ratio per cage: no information
- Length of cohabitation: nop information
- Proof of pregnancy: vaginal plug / sperm in vaginal smear
- Further matings after two unsuccessful attempts: no information
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Prior to mating, throughout the gestation (22 days) and lactation period until post mortem day 3.
Details on study schedule:
- Age at mating of the mated animals in the study: 14 weeks
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Remarks:
Control group
Dose / conc.:
100 mg/kg bw/day
Dose / conc.:
300 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
10
Control animals:
yes

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

OTHER: Effects related to reproduction and hormone balance such as estrous cycle, mating performance, pregnancy rates and the number of embryo resorptions are registered. Pup losses are recorded and the filial generation is examined for behavioural abnormalities and external growth abnormalities.
Oestrous cyclicity (parental animals):
Estrous cycle was monitored.
Sperm parameters (parental animals):
Parameters examined in P male parental generations:
testis weight, epididymis weight

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed

Effect levels (P0)

Key result
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios
reproductive function (oestrous cycle)
reproductive function (sperm measures)
reproductive performance

Target system / organ toxicity (P0)

Key result
Critical effects observed:
no

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed

Effect levels (F1)

Key result
Dose descriptor:
NOEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
clinical signs

Target system / organ toxicity (F1)

Key result
Critical effects observed:
no

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
No adverse effects were observed in all test animals at all doses, the highest dose being 1000 mg/kg/d.
Executive summary:

The reproductive toxicity of the substance was assessed in a an OECD 421 reproductive screening study. Sprague-Dawley rats were randomly assigned to four groups the animals of which were administered with the substance by gavage with 0, 100, 300 and 1000 mg/kg/d. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post mortem).

No effects indicative of general toxicity are observed in parental animals. Relative and absolute weights of testes, epididymides, and seminal vesicles do not differ between test substance and control animals. A marginal reduction is seen in absolute and relative prostate weights in all treated males compared to the control group. A significant difference is found for the low dose group only and no dosedependency was found. Therefore, this finding is not considered to be substance related. With regard to reproductive parameters, no test substance related symptoms are observed. One female in the mid-dose group and two females in the high-dose group did not mate until day 10 and were mated with another male afterwards. One female in the high dose group did not mate after a period of 20 days. Mean litter weights, mean pup weights, sex ratios and gestation periods are similar among all groups. Some slight variations in pre-birth loss are seen in the high-dose group although no significant differences to the controls is found. 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. No adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day. So a NOEL of 1000 mg/kg/day can be established.