Registration Dossier

Diss Factsheets

Administrative data

Description of key information

This substance is used exclusively in personal care products. Because of this, it was not possible to find a laboratory to perform a new OECD TG 422 study in Europe. For this reason, use was made of existing data on an analogue substance.

A study was reported in the literature in which rats were dosed with cetyl betaine (the main constituent of the registered substance) for 91 days at 0, 50, 150 or 350 mg/kg bw/day using a method similar to OECD TG 408. Other than slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material (cetyl betaine) were observed. The NOAEL was established at 350 mg/kg bw/day.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
91 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 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no
Specific details on test material used for the study:
cetyl betaine tested at 32% active adjusted to be delivered at doses of 0, 0.05, 0.15, 0.35 g/kg/day
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
50 mg/kg bw/day (nominal)
Dose / conc.:
150 mg/kg bw/day (nominal)
Dose / conc.:
350 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
attributed to palatability problems of diet
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
slight clinical chemistry signs noted but not detailed
Gross pathological findings:
no effects observed
Dose descriptor:
NOAEL
Effect level:
350 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
not specified
Basis for effect level:
clinical biochemistry
Critical effects observed:
no

All animals survived until end of treatment period; no treatment-related clinical observations; mean body weights and body weight gains significantly decreased in high dose males which was accompanied by significantly decreased total feed consumption – these observations were attributed to palatability problems of diet than toxic effects of test material; slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material observed.

Conclusions:
Although the details in the CIR review are brief and the primary data source is unpublished (Hazleton Laboratories America Inc. 1990. 91-Day subchronic oral toxicity study in rats with Cetyl Betaine. Unpublished data submitted by Personal Care Products Council. 74 pages), the CIR panel consider the result valid.
There appears to be no specifc target organ
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
350 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification