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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulfuric acid, mono-C12-18-alkyl esters, sodium salts
EC Number:
273-257-1
EC Name:
Sulfuric acid, mono-C12-18-alkyl esters, sodium salts
Cas Number:
68955-19-1
Molecular formula:
C12-18H25-37SO4Na
IUPAC Name:
Sulfuric acid, C12-18-alkyl(even numbered) esters, sodium salts
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: White granulate
- Analytical purity: 100% a.i. (statement of data owner)
- Lot/batch No.: BB4872 (02.10.95)
- Storage condition of test material: No data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
According to Guideline.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 12.5%
Challenge: 6.25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 12.5%
Challenge: 6.25%
No. of animals per dose:
Test group: 20
Control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6.25%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
One animal showed as well a reaction when challenged with sterile water.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 6.25%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: One animal showed as well a reaction when challenged with sterile water..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6.25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6.25%. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
2
Total no. in group:
19
Clinical observations:
One animal died accidentially on Day 29.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6.25%. No with. + reactions: 2.0. Total no. in groups: 19.0. Clinical observations: One animal died accidentially on Day 29..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU