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Administrative data

Endpoint:
chronic toxicity: dermal
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:
DERMAL TOXICITY OF SODIUM LAURYL SULFATE
Author:
STEVEN CARSO, BERNARD L. OSER
Year:
1964
Bibliographic source:
J. soc. cos. CHEM. 15, 137-147 (1964)

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 Rabbits 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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Diet : ad libitum
- Water : ad libitum
- Acclimation period : 6 hrs

Administration / exposure

Type of coverage:
other: Intact and abraded skin
Vehicle:
water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
20% solution of SLS in water was applied daily to the intact and abraded skin of rabbits
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
Dosage was applied daily, five days a week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 6, 60 or 150 mg/kg/day
Basis:
nominal per unit area
No. of animals per sex per dose:
Control:
2 males, 1 female
6 mg/kg/day:
3 males, 3 females
60 mg/kg/day:
3 males, 3 females
150 mg/kg/day:
4 males, 2 females
Control animals:
yes, concurrent vehicle
Details on study design:
The dosage levels selected represented 0, 1, 10 and 25% of the acute dermal LD50 (rounded off at 600 mg. per kg.)

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No Data

DETAILED CLINICAL OBSERVATIONS: No Data

BODY WEIGHT: No Data

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: No Data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No Data

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 Data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No Data

OPHTHALMOSCOPIC EXAMINATION: No Data

HAEMATOLOGY: Yes
- total erythrocyte counts, Hematocrit, hemoglobin, total and differential leukocyte counts were conducted initially prior to start of dosage and at 21 and 90 days

CLINICAL CHEMISTRY: Yes
- blood glucose and urea nitrogen concentration were conducted initially prior to start of dosage and at 21 and 90 days

URINALYSIS: Yes
- urine analyses were conducted initially prior to start of dosage and at 21 and 90 days.

NEUROBEHAVIOURAL EXAMINATION: No Data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
All the abraded rabbits and one male and one female each of the intact skin group were sacrificed at 21 days and the remainder of the intact animals at 90 days. Those that died and the survivors were autopsied and all major tissues fixed in 10% formalin.

HISTOPATHOLOGY: Yes
Nine tissues including thyroid, pancreas, heart, liver, kidneys, adrenals, skin, brain and bone marrow were processed, stained with hematoxylin and eosin and examined microscopically

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not examined
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:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
Clinical signs and mortality :
Two rabbits at the 150 mg. per kg. level died, one on the 21st day and one on the 56th day of the test

Body weight and weight gain :
There is no significant differences in growth responses between the untreated controls and those sacrificed at 21 days. These latter rabbits generally tended to show maintenance or a slight loss of body weight. Those that continued on test for 90 days generally showed a slight weight gain.

Haematology :
No significant alterations in total erythrocytes, hemoglobin or Hematocrit values

Clinical chemistry :
Blood glucose and urea nitrogen values reveal no aberrant findings at either 21 or 90 days.

Gross pathology :
Gross examination at necropsy failed to indicate any significant dose-related alterations in tissue pathology. Only the two rabbits that died in the group receiving SLS at 150 mg. per kg. showed evidence of significant deleterious gross change. Necropsy observations in rabbit that died at 21 days revealed marked diarrhea and mucosal sloughing of the gastrointestinal tract. Death appeared to be unrelated to the test treatment. The animal that died after 56 days of test showed evidence of pulmonary congestion, the lungs appearing consolidated and hemorrhagic with moderate quantities of fluid in the pleural cavity.

Histopathology :
No significant systemic tissue changes observed

Effect levels

open allclose all
Dose descriptor:
LOAEL
Effect level:
150 other: mg/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Mortality, body weight, Hematology, Clinical chemistry, Gross pathology, histopathology
Dose descriptor:
NOAEL
Effect level:
60 other: mg/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Mortality, body weight, Hematology, Clinical chemistry, Gross pathology, histopathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The Low Observed Adverse Effect Level (LOAEL) of Sodium Lauryl Sulphate in a 90-day study on rabbits was observed at a dose concentration of 150 mg/kg/day.

The No Observed Adverse Effect Level (NOAEL) of Sodium Lauryl Sulphate in the same study was observed at a dose concentration of 60 mg/kg/day.
Executive summary:

The purpose of this study was to evaluate the toxicity of Sodium Lauryl Sulphate by dermal application.20% solution of Sodium Lauryl Sulphatein water was applieddaily, for five days a week,for 90 daysto the intact and abraded skin of rabbits at a dose concentration of0, 6, 60 or 150 mg/kg/day.Animals were kept in stocks for six hours and allowed food and water ad libitum each day. They were removed from the stocks and returned to their cages at the end of six hours.

Mortality, body weight, hematology, clinical chemistry, gross pathology, and histopathology were analyzed.

Two rabbits died on day 21 and 56 at the highest dose. Slight weight gain was observed for those that continued on test for 90 days. No significant alterations in total erythrocytes, hemoglobin, hematocrit, blood glucose and urea nitrogen values. Gross examination at necropsy failed to indicate any significant dose-related alterations in tissue pathology. Hence the NOAEL and LOAEL was considered to be 60 and 150 mg/kg/day respectively.