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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

The NOAELs for maternal toxicity, embryotoxicity fetotoxicity, and teratogenicity for lauryl glucoside (read-across substance) were all 1000 mg/kg bw day

There were no test article-related effects on reproductive parameters for the parents.

There were no treatment-related effects observed for the neonates

Link to relevant study records

Referenceopen allclose all

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 days in total
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Principles of method if other than guideline:
Lauryl glucoside (as APG C12-C14 fatty alcohol from renewable sources, n: 1.43) was given orally, by gavage, to groups of 10 male and 10 female Sprague-Dawley rats at doses of 0, 0. l, 0.3, or I g kg/day, from 2 weeks prior to mating to 4 days after delivery.
GLP compliance:
not specified
Remarks:
Review document does not give these details.
Specific details on test material used for the study:
Lauryl glucoside (as APG C12-C14 fatty alcohol from renewable sources, n: 1.43)
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on exposure:
Groups of 10 male and 10 female Sprague-Dawley rats were given doses of 0, 0. l, 0.3, or I g kg/day, daily from 2 weeks prior to mating to 4 days after delivery.
Duration of treatment / exposure:
From 2 weeks prior to mating to 4 days after delivery.
Frequency of treatment:
Daily
Dose / conc.:
0 mg/kg bw/day
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:
Implied 10 female and male rats per dose.
Control animals:
yes, concurrent no treatment
Parental animals: Observations and examinations:
No signs of general toxicity were observed in the parental animals
The relative and absolute weights of the testes, epididymides, and seminal vesicles were similar for treated and control animals. There were no test article-related effects on reproductive parameters.
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
clinical signs
gross pathology
Clinical signs:
no effects observed
The mean litter weights, mean pup weights, sex ratio, and gestation period were similar for all the groups; a slight variation in prebirth loss observed in the high-dose group was not statistically significant. There were no treatment-related effects observed for the neonates.
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
Key result
Reproductive effects observed:
no
Conclusions:
No signs of general toxicity were observed in the parental animals. The relative and absolute weights of the testes, epididymides, and seminal vesicles were similar for treated and control animals. There were no test article-related effects on reproductive parameters. The mean litter weights, mean pup weights, sex ratio, and gestation period were similar for all the groups; a slight variation in prebirth loss observed in the high-dose group 'vvas not statistically significant. There were no treatment-related effects observed for the neonates.
The NOAELs are assessed as I g/kg bw day
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
20 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
Principles of method if other than guideline:
Groups of 24 gravid female Sprague-Dawley CD rats were dosed orally, by gavage, with 0, 0. l, 0.3, or I g kg bw/day lauryl glucoside (as CIO-14 or C 10-16, n: 1.4) on days 6 to 15 of gestation. All animals were killed on day 20 of gestation
GLP compliance:
not specified
Remarks:
Review document does not give these details.
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on exposure:
24 female rats were dosed orally, by gavage, with 0, 0. l, 0.3, or I g kg bw/day lauryl glucoside (as CIO-14 or C10-16, n: 1.4)
Duration of treatment / exposure:
Fed daily from day 6 - 15 of gestation
Frequency of treatment:
Daily
Dose / conc.:
0 mg/kg bw/day
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:
Assumed 6 female rats per dose (24 female rats in total)
Control animals:
yes, concurrent no treatment
Details on study design:
All animals were killed on day 20 of gestation
Postmortem examinations (parental animals):
No maternal toxicity was observed, and no reproductive or developmental effects were indicated. There were also no differences in external, visceral, or skeletal malformations
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
clinical signs
gross pathology
Remarks on result:
not measured/tested
Remarks:
This test was done solely on the parent rats. No second generation tests were carried out
Key result
Reproductive effects observed:
no
Conclusions:
The NOAELs for maternal toxicity, embryotoxicity fetotoxicity, and teratogenicity were all I g/kg bw day
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat

Justification for classification or non-classification

Additional information