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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: HRIPT(Human Repeat Insult Patch Testing)
Deviations:
not specified
Principles of method if other than guideline:
Use repetitive epidermal contact to determine the potential of the title compound to induce primary or cumulative irritation and/or allergic contact sensitization.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
There is a weight of evidence from human patch testing so the need for animal testing was not deemed necessary.

Test material

Constituent 1
Chemical structure
Reference substance name:
D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts
EC Number:
664-492-4
Cas Number:
742087-49-6
Molecular formula:
(C6O6H3R1)nC3O4SHNa
IUPAC Name:
D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts
Details on test material:
- Name of test material (as cited in study report): SugaNate 160
- Physical state: slightly viscous clear liquid
- Purity: 40% AS

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml of the test material (SugaNate 160)
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml of the test material (SugaNate 160)
No. of animals per dose:
6

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3 x week 9 aplications (10% SugaNate) 0.5ml path
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3 x week 9 aplications (10% SugaNate) 0.5ml path
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
barely perceptible or spotty erithema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: barely perceptible or spotty erithema.
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Remarks:
negative control group not used - not required for human patch testing
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
positive control group not used - not necessary in human patch testing

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, test material Suga®Nate 160, lot # 19518D08, did not indicate a potential for dermal irritation or allergic contact sensitization.