Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate

Repeated dose toxicity: dermal

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

Test material information

Constituent 1

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

1

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

2

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.