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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 hours on occluded skin
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 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
No details given in the review report.
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
94.9% pure

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Groups of 5 male Sprague-Dawley rats received the test material dermally on clipped trunks; test sites were occluded for 24 h, after which the test sites were wiped clean of the test material
Duration of exposure:
24 hours
Doses:
not specified
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 other: g/kg
Based on:
test mat.
Clinical signs:
Erythema, edema, desquamation, necrosis, and scab formation observed on test sites for test material, as was sluggishness and reddish nasal and ocular discharges; body weight gains within normal parameters; no treatment-related changes due to either test material observed at gross necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cetyl betaine is not harmful by skin absorption.