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Toxicological information

Skin sensitisation

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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

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 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)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1ml of 0.1% solution of Sodium lauryl sulphate
Challengeopen allclose all
Route:
intradermal
Vehicle:
physiological saline
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.

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