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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Toxicity of Sodium Lauryl Sulphate, Sodium Lauryl Ethoxysulphate and Corresponding Surfactants Derived from Synthetic Alcohols
Author:
A. I. T. WALKER, V. K. H. BROWN, L. W. FERRIGAN, R. G. PICKERING and D. A. WILLIAMS
Year:
1967
Bibliographic source:
Food Cosmetic. Toxicology. Vol. 5, pp, 763-769 1967

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Toxicity of Sodium Lauryl Sulphate was assessed in Rats in a 90 day study
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dodecyl sulphate
EC Number:
205-788-1
EC Name:
Sodium dodecyl sulphate
Cas Number:
151-21-3
Molecular formula:
C12H25NaO4S
IUPAC Name:
sodium dodecyl sulfate
Details on test material:
- Name of test material : Sodium Lauryl Sulphate (sodium dodecyl sulphate)
- Molecular formula :NaC12H25SO4
- Molecular weight : 288.372
- Substance type: Organic
- Physical state : Solid
- Purity : 14% (sodium sulphate, sodium chloride, unsulphated feedstock and water)

Test animals

Species:
rat
Strain:
other: Carworth Farm 'E'
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Age at study initiation: 5 wk
- Housing : individually caged
- Diet : Diet 86 powder ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: Diet 86 powder
Details on oral exposure:
DIET PREPARATION
- The test substance was mixed at various concentration in Diet 86 powder
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days (14 weeks)
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 40, 200, 1000 or 5000 ppm (0,2,10,50,250 mg/kg bw/day) respectively
Basis:
nominal in diet
No. of animals per sex per dose:
Control: 18 males and 18 females
40 ppm:
12 males and 12 females
200 ppm:
12 males and 12 females
etc

Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Daily observations were made on health

DETAILED CLINICAL OBSERVATIONS: Not determined

BODY WEIGHT: Yes
- Recorded weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Recorded weekly

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not determined

OPHTHALMOSCOPIC EXAMINATION: Not determined

HAEMATOLOGY: Yes
- Terminal blood samples were taken by cardiac puncture. Erythrocyte and leucocyte counts and determinations of Hematocrit and hemoglobin were made.

CLINICAL CHEMISTRY: Yes
- Total plasma protein and urea concentrations were determined, the serum protein fractions being determined by paper electrophoresis using LKB paper electrophoresis equipment

URINALYSIS: Yes
- Urine samples were obtained from the 5000 ppm and control groups during wk 12 on test by placing the rat in a metabolic cage for 16 hr and collecting the urine voided. The urine was examined for colour, pH, protein, reducing substances, bile salts and microscopic constituents.

NEUROBEHAVIOURAL EXAMINATION: Not determined
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
At autopsy, gross pathological examination was carried out and the major visceral organs were weighed

HISTOPATHOLOGY: Yes
Sections of a wide range of organs from rats of the 5000 ppm and control groups were processed for histological examination.
Statistics:
Statistical analyses of terminal body weights, food intakes and organ weights were made using the initial body weight as a covariate in covariance analysis.

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):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Details on results:
Clinical signs and mortality
Normal Health, behaviour was observed

Body weight and weight gain
Body weight remained within normal limits

Food consumption and compound intake
Food intake remained within normal limits

Food efficiency
Not determined

Ophthalmoscopic examination
Not Determined

Haematology
Haematological studies shows that the values of hemoglobin, Hematocrit, PVC, RBC WBC counts were within the normal limits

Clinical chemistry
Clinical chemical examinations of the blood revealed an increased serum urea concentration in females of high dose group

Urinanalysis
Urinary pH, color, protein, bile salts remained within the normal limits

Neurobehaviour
Not determined

Organ weights
Significant increases in absolute organ weights were confined to the highest dietary level but corresponding increases in relative organ weights did not attain statistical significance due to the non-significant increase in body weight

Gross pathology
At autopsy, no evidence of pathological change was obtained.

Histopathology
Spontaneous lesions, mainly hydronephrosis, were present in all groups of animals.

Details on results
Organ Weight:
The sulphates, C1 and D1, did not affect male organ weights, but C1 and D1 increased the liver weights and D1 the spleen and kidney weights of the 5000 ppm females.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: body weight, Organ weight, Clinical chemistry food intake, hematology, Urinalysis, gross pathology, Histopathology
Dose descriptor:
LOAEL
Effect level:
250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: body weight, Organ weight, Clinical chemistry food intake, hematology, Urinalysis, gross pathology,Histopathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The No Observed Adverse Effect Level (NOAEL) of Sodium Lauryl Sulphate in rat in a 90 day study was observed at a dose concentration of 50 mg/kg bw/day.

The Low Observed Adverse Effect Level (LOAEL) of Sodium Lauryl Sulphate in rat in the same study was observed at a dose concentration of 250 mg/kg bw/day.
Executive summary:

The purpose of this study was to evaluate the toxicity ofSodium Lauryl Sulphate in Carworth Farm 'E' Rats. In 90 days feeding study Carworth Farm 'E' Rats were administeredSodium Lauryl Sulphate at a dose concentration of0,40, 200, 1000 or 5000 ppm (0, 2, 10, 50 or 250 mg/kg bw/day) respectively. Body weight, organ weight, clinical chemistry food intake, hematology, urinalysis, gross pathology and histopathology were observed.

The health, behaviour, body weight and food intake, haematological and urinary findings were found within normal limits. There was an increase in serum urea concentration in females and inserum total protein concentration of males at higher dose. The organ weight and blood chemistry effects observed were unaccompanied by any pathological changes.

 Hence,The No Observed Adverse Effect Level (NOAEL) andLow Observed Adverse Effect Level (LOAEL) was considered to be 50 and250 mg/kg bw/day, respectively.

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