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Toxicological information

Repeated dose toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Doses / concentrationsopen allclose all
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

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
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
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
attributed to palatability problems of diet
Gross pathological findings:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Effect level:
350 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
not specified
Basis for effect level:
clinical signs

Target system / organ toxicity

Critical effects observed:
no

Any other information on results incl. tables

Other than slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material were observed

Applicant's summary and conclusion

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