Registration Dossier

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:
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 group
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 group
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.