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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before the implementation of the REACH regulation

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
478-900-1
EC Name:
-
Cas Number:
6156-18-9
Molecular formula:
C5 H12 S2
IUPAC Name:
2,2-bis(methylthio)propane
Details on test material:
- Name of test material (as cited in study report): BISMETHYLTHIOPROPANE
- Synonym: BMTP
- Chemical name: 2,2-bis-methylthiopropane
- Batch number: 2KS149
- Description: colorless liquid
- Storage conditions: at room temperature and protected from light
- Purity test date: 2006-11-08
- Purity: 97.76%
- Expiry date: November 2007.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France
- Age at study initiation: 1-2 months old
- Weight at study initiation:
Male: 352 +/- 12 g
Female: 354 +/-21 g
- Housing: housed individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm)
- Diet: free access to 106 pelleted diet (SAFE, Villemoisson, Epinay sur-Orge, France)
- Water: water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr):12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 20 December 2006 to 02 February 2007

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: corn oil (i.d. induction) and acetone (challenge)
Concentration / amount:
Induction:
- 10% in corn oil intradermal
- undiluted topically
Challenge:
10% (w/w) in acetone topically
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil (i.d. induction) and acetone (challenge)
Concentration / amount:
Induction:
- 10% in corn oil intradermal
- undiluted topically
Challenge:
10% (w/w) in acetone topically
No. of animals per dose:
Test group: 20
Negative control group: 10
Details on study design:
RANGE FINDING TESTS:
By intradermal route: tested concentrations: 25%, 10% and 5% (w/w)
By cutaneous route
Under the conditions of the induction phase: tested concentrations: 100% and 50% (w/w)
Under the conditions of the challenge phase: tested concentrations: 100%, 50%, 25% and 10% (w/w)
Challenge controls:
The vehicle was applied under the same experimental conditions to the skin of the posterior left flank.
Positive control substance(s):
yes
Remarks:
Mercaptobenzothiazole

Results and discussion

Positive control results:
Mercaptobenzothiazole induced positive skin sensitization reactions in 100% (10/10) guinea pigs

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Signs of irritation during induction:
yes

Evidence of sensitisation of each challenge concentration:
No cutaneous reactions were observed after the challenge application of the test item.

Other observations:
No deaths and no clinical signs were noted during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The potential of BISMETHYLTHIOPROPANE (BMTP) to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD guideline 406. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals:

. Freund's complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups),

. BMTP at the concentration of 10% in corn oil (treated group) or vehicle alone (control group),

. BMTP at the concentration of 10% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group).

On day 8, the animals of the treated group received a topical application of the undiluted BMTP to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle (ethanol/water (80/20, w/w) under the same experimental conditions. On day 22, all animals of both groups were challenged by a cutaneous application of BMTP at the concentration of 10% (w/w) in acetone to the right flank. BMTP was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions.Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing. At the end of the study, the animals were killed without examination of internal organs.

No deaths and no clinical signs were noted during the study. No cutaneous reactions were observed after the challenge application of BMTP. Under the experimental conditions of this study and according to the maximization method of Magnusson and Kligman, BISMETHYLTHIOPROPANE did not induce delayed contact hypersensitivity in guinea pigs.