Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

THE IDENTIFICATION OF CONTACT ALLERGENS BY ANIMAL ASSAY. THE GUINEA PIG MAXIMIZATION TEST5

Author:

BERTIL MAGNUSSON, MD.t AND ALBERT M. KLIGMAN

Year:

1969

Bibliographic source:

THE JOURNAL OF INVESTIGATIVE DERMATOLOGY Copyright 1969 vol. 52, No. 3

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Potential of Sodium lauryl sulphate to cause contact allergy was assessed in Albino guinea pigs by draize test

GLP compliance:

not specified

Type of study:

Draize test

Justification for non-LLNA method:

The study Albino guinea pigs by draize test is present which confirms the classification of the substacne so the new LLNA study was not conducted

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 dodecyl Sulphate
- Molecular formula : NaC12H25SO4
- Molecular weight : 288.372
- Substance type : Organic
- Physical state : Solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

- Weight at study initiation : 300-500 gram

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Induction 2

Concentration / amount:

0.1ml of 0.1% solution of Sodium lauryl sulphate

Challenge

Challenge 1

Route:

intradermal

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

0.1ml of 0.1% solution of Sodium lauryl sulphate

No. of animals per dose:

25

Details on study design:

A. INDUCTION EXPOSURE
- No. of exposures: 10 exposures
- Exposure period: 2 weeks
- Test groups:
- Control group: no data
- Site: intradermal injection
- Frequency of applications: Daily
- Duration: 2 weeks
- Concentrations: 0.1 ml

B. CHALLENGE EXPOSURE
- No. of exposures: one exposure
- Day(s) of challenge: After 2weeks of induction exposure
- Exposure period: 24 hrs
- Test groups:
- Control group: No data
- Site: intradermal injection
- Concentrations: 0.05 ml
- Evaluation (hr after challenge): 24 hrs

OTHER:

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 ml induction exposure, 0.05 ml challenge exposure

No. with + reactions:

0

Total no. in group:

25

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml induction exposure, 0.05 ml challenge exposure . No with. + reactions: 0.0. Total no. in groups: 25.0.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance Sodium lauryl sulphate was found to be weakly sensitizing to Hartley Albino guinea pigs in 2 weeks study by standard Draize test

Executive summary:

The standard Draize test was carried out todetermine the sensitization potential of Sodium lauryl sulphate. 0.1 ml solution of sodium lauryl sulphate was injected intradermally to 3 to 4 cms square area of skin. The application was repeated every other or three time a week for a total of ten. The site was read 24 hours after each injection. Two weeks after the 10th injection, the animals were challenged by an intradermal injection of 0.05 ml into a fresh skin area. The animal was judged to be sensitized if the reaction was clearly greater than the average reaction of the inducing injections. Sodium lauryl sulphate was found to be weakly sensitizing to skin of guinea pig with score of 1.