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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 with acceptable restrictions

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
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:
mouse
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

General toxicity (maternal animals)

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.
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)
Based on:
test mat.
Basis for effect level:
dead fetuses
number of abortions
total litter losses by resorption

Results (fetuses)

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)
Based on:
test mat.
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:
Tthe NOAEL (developmental toxicity) for the APG-C12/C16 is 1000 mg/kg (the highest dose tested)