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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Validity of the study assessmed by the CIR Expert Panel

Data source

Reference
Reference Type:
review article or handbook
Title:
Final report on the safety assessment of alkyl sarcosines and sodium alkyl sarcosinates
Author:
Cosmetic Ingredient Review Panel
Year:
2001
Bibliographic source:
Int. J. Toxicol. 20: 1-14, 2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: 2-year feeding toxicity study
Version / remarks:
The study integrates the mating of males and females
Principles of method if other than guideline:
2-year feeding toxicity study
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Sodium lauroyl sarcosinate
IUPAC Name:
Sodium lauroyl sarcosinate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
daily (feeding)
Doses / concentrationsopen allclose all
Dose / conc.:
20 000 mg/kg diet
Remarks:
0.05% of the test item in the diet for the first 6 months and 2.0% of the test item in the diet for the remaining 18 months

Dose / conc.:
10 000 mg/kg diet
Remarks:
1.0% of the test item in the diet for 24 months
Dose / conc.:
2 000 mg/kg diet
Remarks:
0.2% of the test item in the diet for 24 months

Dose / conc.:
0 mg/kg diet
Remarks:
Basal diet alone
No. of animals per sex per dose:
25 per sex per group
Control animals:
yes, plain diet

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
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:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
hyperplasia of squamous epithelium with keratin formation of the mucosa of the stomach at two highest dose groups
Histopathological findings: neoplastic:
not specified

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
20 000 mg/kg diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no effect up to the highest dose

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Citation:

"...Two hundred albino Sherman Wistar rats (25 rats/sex/group; 100-150 g) were fed Sodium Lauroyl Sarcosinate during a 2-year chronic oral toxicity study. Group 1 was fed 0.05% Sodium Lauroyl Sarcosinate in the daily diet for the first 6 months of the study and 2.0% of dies for the remaining 18 months. For the entire study period, group 2 was fed 0.2% of diet, group 3 was fed 1.0% of diet, and group 4 was fed the basal diet alone. Rats were killed at 1,3,6, and 24 months for necropsy and tissues collected for microscopic examination; organs examined included the liver, spleen, heart, lungs, stomach, large intestine, small intestine, adrenal glands, gonads, pancreases, and brain. Blood samples were drawn and analyzed at 30 days, 90 days, 6 months, and 24 months for red and white blood cell counts, hemoglobin content, and differential count. Males and females were housed together so that ferility could be assessed. At 1,3,6 months, no significant differences were observed in lesions, fertility, mortality, hematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test article was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test article-group1 (2% in the diet after 6months) and group 3 (1% in the diet)...."

Applicant's summary and conclusion

Conclusions:
Sodium N-Lauroyl sarcosinate was investigated in rats for its chronic toxicity and reproduction toxicity in a 2 -year feeding study. The doses levels applied were 0, 0.2, 1 and 2% in the diet. Males and females were housed together so that fertility could be assessed. No effect on the fertility was found. Histopathological changes of stomach tissues were evident at dose levels of 1 and 2% in the diet. No significant systemic effect was found up to the highest dose level.
Executive summary:

The subacute toxicity of the registration substance Hostapon SLG was evaluated based on the read-across approach using the repeated dose toxicity data for sodium N-lauroyl sarcosinate

The registration substance and the read-across sources are amides of fatty acids and amino acids and can be characterized as "N-fatty acyl amino acids", of which endogeous occurence and metabolism are known. Based on the comparable chemical structure, comparable phys-chem data and expected comparable metabolism, these compounds are likely exhibit comparable toxicity profiles.

Sodium N-lauroyl sarcosinate was investigated in rats for its chronic toxicity and reproduction toxicity in a 2 -year feeding study. The doses levels applied were 0, 0.2, 1 and 2% in the diet. Males and females were housed together so that fertility could be assessed. No effect on the fertility was found. Histopathological changes of stomach tissues were evident at dose levels of 1 and 2% in the diet. No significant systemic effect was found up to the highest dose level.

Likewise, the registration substance Hostapon SLG is likely of low repeated dose toxicity.