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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries( JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This method was selected by the study sponsor.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
452-830-1
EC Name:
-
Molecular formula:
C27 H44 N2 Na2 O6 S3
IUPAC Name:
Equimolecular mixture of - Disodium 2-Hexadecylsulfanyl-1-(4-sulfo-butyl)-1H- benzoimidazole-5-sulfonate - Disodium 2-Hexadecylsulfanyl-3-(4-sulfo-butyl)-1H- benzoimidazole-5-sulfonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Strain: Albino guinea pig, Dunkin Hartley

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 0.05% in water
Epidermal: 50% in water
Approximately 24 hours before the epidermal induction
exposure all animals were treated with 10% SDS.

Concentration of test material and vehicle used for each challenge:
50% in water
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 0.05% in water
Epidermal: 50% in water
Approximately 24 hours before the epidermal induction
exposure all animals were treated with 10% SDS.

Concentration of test material and vehicle used for each challenge:
50% in water
No. of animals per dose:
Number of animals in test group: 10 females
Number of animals in negative control group: 5 females
Positive control substance(s):
yes
Remarks:
Alpha-hexylcinnamicaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
20% alpha-hexylcinnamicaldehyde
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Remarks:
Reliability check performed within 6 months of the study. NOTOX Project 390364
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
20% alpha-hexylcinnamicaldehyde
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Remarks:
Reliability check performed within 6 months of the study. NOTOX Project 390364

Any other information on results incl. tables

Results of the preliminary irritation study:

- For the induction exposures: the highest possible concentration that produced irritation was 0.05% (for the intradermal induction) and 50% (for the epidermal induction). As no signs of irritation were observed to the highest test substance concentration epidermally tested, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction.

- For the challenge exposure: the maximum non-irritant concentration was 50%.


Main study:

1. induction phase:

Intradermal - erythema (experimental animals): 6 animals grade 0, 4 animals grade 1

Intradermal - erythema (control animals): all animals grade 0

Epidermal - erythema (experimental animals): 5 animals grade 0, 4 animals grade 1, 1 animal grade 2

Epidermal - erythema (control animals): all animals grade 0

The reactions noted in the experimental animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment.

2. challenge phase: No skin reactions were evident after the challenge exposure in the experimental and control animals.

3. toxicity/mortality: No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

4. body weights: body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0%.