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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Only 10 animals in positive test group.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
other: Alembicol D
Concentration / amount:
a) for induction:
Intradermal injections: 0.1% concentration in Alembicol D
Topical application: 50% concentration in Alembicol D
b) for challenge:
Topical application: 20% concentration in Alembicol D
Route:
epicutaneous, open
Vehicle:
other: Alembicol D
Concentration / amount:
a) for induction:
Intradermal injections: 0.1% concentration in Alembicol D
Topical application: 50% concentration in Alembicol D
b) for challenge:
Topical application: 20% concentration in Alembicol D
No. of animals per dose:
10 females
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1 – intradermal injection (0.1% concentration in Alembicol D injected at a volume of 0.1ml)
Day 8 – Topical applcation of (50% concentration in Alembicol D covered with 0.4ml of the substance)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Concentrations: 20%
- Evaluation (hr after challenge): 24 and 48

Positive control substance(s):
no
Positive control results:
No positive control used; reliability check satisfactory
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
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: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
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: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DMDMH was not sensitising to guinea pig skin (not classified)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

DMDMH is not a skin sensitiser in either a Buehler or M&K Maximisation assay. DMH is also not a skin sensitiser.


Migrated from Short description of key information:
DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances. Both DMDMH and DMH are not skin sensitisers.

Justification for selection of skin sensitisation endpoint:
Two studies available on DMDMH. Both studies were Klimisch 1 however this study was conducted to the maximisation protocol.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

DMDMH is not a skin sensitiser and therefore is not classified.