Registration Dossier

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
Study period:
17/11/1999 to 16/12/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study with sufficient documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal
Vehicle:
other: aceton
Concentration / amount:
Induction 20% / chalange 0.1%
Route:
epicutaneous, occlusive
Vehicle:
other: aceton
Concentration / amount:
Induction 20% / chalange 0.1%
No. of animals per dose:
20 animals fot test
Positive control substance(s):
yes
Remarks:
Hexyl cinnamic aldehyde
Positive control results:
8/10 animals had a "positive skin reaction"
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0,1
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0,1
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2-Chloro-4,6-Dimethoxy-1,3,5-Triazin (CDMT) according to this test needs to be classified as sensitising
Executive summary:

In the 2-Chloro-4,6-Dimethoxy-1,3,5-Triazin (CDMT) group, very slight to severe erythema and/or oedema were noted in 17/20 animals at the test susbstance treated areas 24 or 48 hours after the end of the challenge exposure. As the control sites of all animals were normal, 17/20 animals (85% of the test susbstance group animals) were regarded as sensitised.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

see below


Justification for selection of skin sensitisation endpoint:
guideline study sufficiently documented

Justification for classification or non-classification

In the 2-Chloro-4,6-Dimethoxy-1,3,5-Triazin (CDMT) group, very slight to severe erythema and/or oedema were noted in 17/20 animals at the test susbstance treated areas 24 or 48 hours after the end of the challenge exposure. As the control sites of all animals were normal, 17/20 animals (85% of the test susbstance group animals) were regarded as sensitised.