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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
Study period:
19.7.1991-30.7.1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Soviet union (Estonia) national standards
Version / remarks:
Year 1990 national standards, approved by Health ministry.
GLP compliance:
not specified
Type of study:
other: According to National standard of Estonia (Soviot Union) 1990
Justification for non-LLNA method:
Method according to national standars, from year 1990 according to best test methods of that time.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
EC Number:
288-492-5
EC Name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
Cas Number:
85736-79-4
Molecular formula:
Sulfonic acid, C13-17-sec-alkane: C13H28O3S (MW 264,42) - C17H36O3S (MW 320,53) and 2,2',2''-nitrilotriethan: C6H15NO3 (MW 149,19) , typical medium molecular weight of mixture 454 g/mol.
IUPAC Name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
Test material form:
liquid: viscous
Specific details on test material used for the study:
Fain, 1990

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
500 g weight animals.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
2.5 g/kg, 2 g/kg, 0.6 g/kg
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
2,5 g/kg
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
50
Details on study design:
The sample was used at the amounts of 2,5 g, 1,2 g and 0,6 g / weight kilogram.
Challenge controls:
As a reference, a Krja-Krja-shampoo and Physiologial solution was tested.
Positive control substance(s):
not specified
Remarks:
according to national standards

Results and discussion

Positive control results:
Not specified, according to national standards. Full information not available in English/Finnish.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: not specified
Group:
test chemical
Dose level:
2,5 g/Kg maximum
No. with + reactions:
0
Total no. in group:
50
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: not specified
Group:
negative control
Dose level:
2,5 g/kg maximum
No. with + reactions:
0
Total no. in group:
50
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: not specified
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
information not available
Remarks on result:
other: information not available

Any other information on results incl. tables

Only Certificate and Summary available in Finnish language, none in english. Therefore all information is not complete here.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although all information is not available to us, the results are clear and based on the national standards and made by relialable laboratory, confirmed by authoroties. As a conclusion, Fain did not cause skin sensitisation.
Executive summary:

Fain did not cause skin sensitisation.