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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
other: Study meets generally accepted scientific principles, acceptable for assessment Adopted according to OECD SIDS or other official EU regulation procedures (public available peer reviewed source).
Justification for type of information:
Refer to the Analogue Approach Justification document provided in Section 13

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1977
Reference Type:
secondary source
Title:
SIDS Category of Alkyl sulfates, Alkane sulfonates and Alpha-olefin sulfonates
Author:
OECD
Year:
2007
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: Unilever in-house protocol
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Constituent 1
Reference substance name:
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
EC Number:
287-809-4
EC Name:
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Cas Number:
85586-07-8
Molecular formula:
C12-14H25-29SO4Na
IUPAC Name:
Sulfuric acid, C12-14-alkyl (even numbered) esters, sodium salts

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Vehicle:
other: intradermal injection: saline; topical application: distilled water
Challenge
Vehicle:
other: intradermal injection: saline; topical application: distilled water
No. of animals per dose:
10
Details on study design:
1st application: Induction 0.08% intracutaneous
2nd application: Induction 0.5% occlusive epicutaneous
3rd application: Challenge 0.1% occlusive epicutaneous

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

0/10 guinea pigs sensitised after 2 challenges

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met