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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
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 alkyl polyglucosides on development and fertility
Author:
H. Messinger, W. Aulmann, M. Kleber, W. Koehl
Year:
2007
Bibliographic source:
Food and Chemical Toxicology
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
CD-1

Administration / exposure

Route of administration:
oral: gavage
Frequency of treatment:
Daily exposure between day 6 and day 15 of gestation
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
300 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Description (incidence and severity):
all females had viable foetuses (with or without treatment) and pre- and post-implantation loss as well as numbers of resorption were not affected by treatment whatever the doses
Description (incidence and severity):
No lethality was observed on all pups

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
number of abortions
total litter losses by resorption
dead fetuses

Results (fetuses)

Description (incidence and severity):
skeletal and visceral examinations did not show malformations
Description (incidence and severity):
skeletal and visceral examinations did not show malformations
Description (incidence and severity):
skeletal and visceral examinations did not show malformations

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
reduction in number of live offspring
skeletal malformations
visceral malformations

Overall developmental toxicity

Key result
Developmental effects observed:
no
Relevant for humans:
yes

Applicant's summary and conclusion

Conclusions:
The NOAEL (developmental toxicity) for the APG-C12/C16 is 1000 mg/kg (the highest dose tested)