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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
TOXICITY STUDIES OF TETRADECANOIC ACID, 2-SULFO-, 1-METHYLESTER, SODIUM SALT (C14-MES)
Author:
Jun SATO, Yasuhito YAMAMOTO, Tsuneaki NAKAMURA, Shigeru ISHIDA and Yutaka TAKAGI
Year:
2005
Bibliographic source:
The Journal of Toxicological Sciences, Vol.30, No.4, 339-347, 2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study from 2005

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-methyl 2-sulphonatotetradecanoate
EC Number:
223-675-5
EC Name:
Sodium 1-methyl 2-sulphonatotetradecanoate
Cas Number:
4016-22-2
Molecular formula:
C15H30O5S.Na
IUPAC Name:
sodium 1-methoxy-1-oxotetradecane-2-sulfonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
purchased from Charles River Laboratories France (L’Arbresle Cedex, France)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
0.1% intradermal
Day(s)/duration:
On Day 0
Adequacy of induction:
not specified
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
5% in induction patch
Day(s)/duration:
On day 7
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
5% or 2%
Day(s)/duration:
On Day 14
Adequacy of induction:
not specified
No. of animals per dose:
10
Details on study design:
We administered 0.1% C14-MES by intradermal injection into the shoulder of 10 guinea pigs on Day 0.
On Day 7, we applied a 48-hr filter paper (Whatman International Ltd, UK) induction patch containing 5% C14-MES to the injection site. Pretreatment with 0.5 mL of a suspension of 10% sodium lauryl sulphate in vaseline oil was performed 24-hr before the patch. We treated negative control animals with vehicle and positive control animals with 1% dinitrochlorobenzene (DNCB, Sigma). After 14 days, we applied 5% or 2% C14-MES on filter paper to the flank of animals as a 24-hr occlusive patch. We graded the skin reaction at 24 and 48-hr.
Positive control substance(s):
yes
Remarks:
1% dinitrochlorobenzene

Results and discussion

In vivo (non-LLNA)

Results
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Remarks:
The substance showed no allergenic potency in the male guinea pig under the experimental conditions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance under investigation showed no allergenic potency in the male guinea pig under the experimental conditions.
Executive summary:

A skin sensitization test on the substance under investigation according to the OECD guideline (OECD, 1992; Magnusson and Kligman, 1969) was performed on albino Hartley guinea pigs.

The substance under investigation showed no allergenic potency in the male guinea pig under the experimental conditions.