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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:
weight of evidence
Study period:
Dosing 10 weeks prior to mating and through gestation and lactation
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Taken from review document, Cosmetic Ingredient Review
Accepted international publication for review of safety for cosmetic ingredients.
Review is on tertiary amine triethanolamine; this is a lower molecular weight and more bioavailable than the registered substance and is therefore considered to be a good surrogate for assessing this class of substance.

Data source

Reference
Reference Type:
review article or handbook
Title:
CIR EXPERT PANEL MEETING SEPTEMBER 26-27, 2011
Author:
CIR
Year:
2011
Bibliographic source:
Cosmetic Ingredient Review; Int J Toxicol 32 (3 Suppl): 59S-83S (2013).

Materials and methods

Test guideline
Deviations:
not specified
Principles of method if other than guideline:
A volume of 1.8 ml/kg was applied daily to rats for 10 wks prior to mating, during mating, and through gestation and lactation.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Reported as 'high purity'

Test animals

Species:
rat
Strain:
Fischer 344

Administration / exposure

Route of administration:
dermal
Vehicle:
unchanged (no vehicle)
Details on exposure:
Applied to clipped skin on the back of the rats
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
10 weeks prior to mating and up until lactation
Frequency of treatment:
Daily
Doses / concentrations
Dose / conc.:
1 800 mg/kg bw/day (nominal)
No. of animals per sex per dose:
No specified
Control animals:
not specified

Examinations

Maternal examinations:
Yes

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Description (incidence and severity):
Reported in other part of the same reference that neat material is tolerated,
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
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Changes in number of pregnant:
no effects observed
Other effects:
not specified

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
> 1 800 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: No adverse effects reported
Remarks on result:
not determinable due to absence of adverse toxic effects

Maternal abnormalities

Abnormalities:
no effects observed

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
not specified
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
no effects observed
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed
Other effects:
not specified

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
> 1 800 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects

Fetal abnormalities

Abnormalities:
no effects observed

Overall developmental toxicity

Developmental effects observed:
no

Any other information on results incl. tables

No effect on mating or fertility or offspring growth or survival was observed

Applicant's summary and conclusion

Conclusions:
The secondary data source was very sparce in terms of methodology and results, but the conclusion was accepted as part of the CIR and as such, the substance is used in cosmetic products.