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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviwed journal .

Data source

Reference
Reference Type:
publication
Title:
Acute oral toxicity was carried out to study the effects of test chemical on rats.
Author:
Diamante et. al.
Year:
2010
Bibliographic source:
International Journal of Toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of test chemical in Guinea pig by Guinea pig maximisation test.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified.

Test material

Constituent 1
Chemical structure
Reference substance name:
Didodecyl 3,3'-thiodipropionate
EC Number:
204-614-1
EC Name:
Didodecyl 3,3'-thiodipropionate
Cas Number:
123-28-4
Molecular formula:
C30H58O4S
IUPAC Name:
didodecyl 3,3'-sulfanediyldipropanoate
Test material form:
solid
Details on test material:
Name of the test chemical: didodecyl 3,3'-sulfanediyldipropanoate [Dilauryl thiodipropionate]
Molecular Formula:C30H58O4S
Molecular Weight:514.85 g/mol
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
Test material diluted in FCA(0.1-mL injections of FCA)
Challenge
No.:
#1
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.0025% (undiluted test material)
No. of animals per dose:
Total 14 animals
10 test group
2 positive control
2 Negative control.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: No data available.
- Test groups: 10
- Control group: 4
- Site: Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body.
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: Test material diluted in FCA(0.1-mL injections of FCA,)

B. CHALLENGE EXPOSURE
- No. of exposures: No data available.
- Day(s) of challenge: No data available.
- Exposure period: No data available.
- Test groups: 10
- Control group: 4
- Site: Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body.
- Concentrations: undiluted test material
- Evaluation (hr after challenge): No data available.

Other- Skin sensitization reaction were scored.

Challenge controls:
Negative controls received distilled water
Positive control substance(s):
yes
Remarks:
5% formalin

Results and discussion

Positive control results:
The 2 positive control animals received scores of 3.

In vivo (non-LLNA)

Results
Reading:
other: challenge
Group:
test chemical
Dose level:
0.0025% (undiluted test material)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitization reaction observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing.
Conclusions:
The skin sensitizing test for test chemical was observed in Guinea pig by Guinea pig maximisation test.The test material was considered to be non sensitizing for Guinea pig .
Executive summary:

The skin sensitizing test for test chemical was observed in Guinea pig by Guinea pig maximisation test. Group of 10 Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body. The test guinea pigs received two 0.1-mL injections of FCA, test material diluted in FCA in induction phase. While at challenge 0.0025% undiluted test material were given intradermally to 10 animals. Negative controls received distilled water and positive controls received 5% formalin. There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0. Under the conditions of the study, the makeup foundation containing 0.05% and 0.0025% of test chemical was not a sensitizer. Therefore the test chemical was considered to be non-sensitizing in Guinea pig .