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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (in vivo): Not sensitising (equivalent or similar to OECD 406)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
There are available GPMT , OET , DT and FCAT data and they are enough for hazard assessment for skin sensitization.
Species:
guinea pig
Strain:
other: Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute of Biomedical Research, Füllinsdorf, Switzerland
- Weight at study initiation: 400 to 500g
- Diet (e.g. ad libitum): pelleted feed supplemented with green vegetables, carrots and vitamin C
- Water (e.g. ad libitum): drinking water, ad libitum


Details on study design:
On day 0 the animals were injected intradermally with 0.1 ml of a 5 percent solution of the compound tested, with 0.1 ml of a 5 percent emulsion of the same compound in Freund's complete adjuvant (FCA) and with 0.1 ml of FCA alone, each injection being given twice. In addition, 250 mg of the compound dissolved in petrolatum at a concentration of 25 percent, which always causes mild to moderate skin irritation under occlusionw, asa pplied on day 8 to a clipped skin area of the neck and was kept under occlusive bandage for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously). On day 21 an occlusive patch test with the compound at a subirritant concentrationin petrolatum was applied to the flank for 24 h. The reactions were read 24 and 48 h after removing the patch.
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: open epicutaneous test (OET)
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
There are available GPMT , OET , DT and FCAT data and they are enough for hazard assessment for skin sensitization.
Species:
guinea pig
Strain:
other: Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute of Biomedical Research, Füllinsdorf, Switzerland
- Weight at study initiation: 400 to 500g
- Diet (e.g. ad libitum): pelleted feed supplemented with green vegetables, carrots and vitamin C
- Water (e.g. ad libitum): drinking water, ad libitum

No. of animals per dose:
6 to 8 guinea pigs per concentration group
Details on study design:
Induction procedure:
On day 0 we applied 0.1 ml of each undiluted compound and of its progressively diluted solutions to an area measuring 8cm2 on the clipped flank skin of 6 to 8 guinea pigs per concentration group, using 4 to 6 such groups for each compound. The applications were repeated daily for 21 days, always using the same skin site. The application site was left uncovered and the reactions were read 24h after each application. The maximum nonirritant and the minimal irritating concentrations were determined by the same " all or none" criterion as described above. When necrotic or ulcerating reaction were provoked, the application site was changed.

Challenge procedure:
To determine whether or not allergic contact dermatitis was induced, all the groups of guinea pigs previously treated for 21 days as described above, as well as 6 to 8 untreated controls for each compound, were tested on days 21 and 35 on the contralateral flank with the same compound at the minimal irritating concentration and at some lower concentrations. Minimal irritating concentrations of each compound were used in order to confirm the biological activity determined after the first application and to exclude false results. These tests were performed by applying with a pipeette 0.0025 ml of each concentration to skin areas measuring 2 cm2, the reactions being read after 24, 48 and/or 72 h.

Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: Draize test (DT)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
There are available GPMT , OET , DT and FCAT data and they are enough for hazard assessment for skin sensitization.
Species:
guinea pig
Strain:
other: Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute of Biomedical Research, Füllinsdorf, Switzerland
- Weight at study initiation: 400 to 500g
- Diet (e.g. ad libitum): pelleted feed supplemented with green vegetables, carrots and vitamin C
- Water (e.g. ad libitum): drinking water, ad libitum


Details on study design:
A dose of 0.05 ml of a 0.1 percent solution of the compound tested in isotonic saline was injected intradermally on day 0 and further doses of 0.1 ml each were injected on 9 alternate days (total dose = 0.95 mg). The treated animals and untreated controls were challenged intradermally with 0.05 ml of 0.1 percent solution on days 35 and 49. The evalution criterion was the mean diameter of the papular reaction.
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: Freund's complete adjuvant (FCAT),
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
There are available GPMT , OET , DT and FCAT data and they are enough for hazard assessment for skin sensitization.
Species:
guinea pig
Strain:
other: Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute of Biomedical Research, Füllinsdorf, Switzerland
- Weight at study initiation: 400 to 500g
- Diet (e.g. ad libitum): pelleted feed supplemented with green vegetables, carrots and vitamin C
- Water (e.g. ad libitum): drinking water, ad libitum


Details on study design:
Doses of 0.05 ml of the undiluted compound mixed withe the same volume of FCA were injected intradermally into the neck on days 0, 2, 4, 7 and 9 (total dose 250 mg). The control animals were similarly treated with 5*0.05 ml of FCA alone. All the animals were tested epicutaneously on days 21 and 35.
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no in vitro skin sensitisation studies available for DMBC.

DMBC is not sensitising in a panel of in vivo guinea pig allergenicity tests (Freund's Complete Adjuvant Test, Open Epicutaneous Test, Draize Test, Maximisation Test).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information in the dossier, the substance DMBC (CAS No. 100-86-7) does not need to be classified  for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.