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Diss Factsheets

Administrative data

Description of key information

The Test material produced a 0% (0/9) sensitisation rate and was classified as a non-ssensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk phrase is required.

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:
March 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The presented test has been performed according to OECD 406 before the LLNA test has been made mandatory
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8% in Water
Day(s)/duration:
2
Adequacy of induction:
highest technically applicable concentration used
Route:
intradermal
Vehicle:
water
Concentration / amount:
2% in Water
Day(s)/duration:
2
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
water
Concentration / amount:
6% in Water
Day(s)/duration:
2
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
water
Concentration / amount:
4% in water
Day(s)/duration:
2
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8% in Water
Day(s)/duration:
2
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
6% in Water
Day(s)/duration:
2
Adequacy of challenge:
not specified
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
4% in Water
Day(s)/duration:
2
Adequacy of challenge:
not specified
No.:
#4
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
2%
Day(s)/duration:
2
Adequacy of challenge:
not specified
No. of animals per dose:
2
Positive control substance(s):
no
Positive control results:
no positive control gourpe performed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undilluted
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undilluted. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
2-Sodiumhydroxy-4,6-Dichloro-1,3,5-Triazine (NHDT) is to be classified as "not sensitising"
Executive summary:

Ten test and five control animals were used for the main study.

Based on the results of sighting tests, the concentrations of test material for the induciton and challenge phase were selected as follows:

Intradermal Induction : 25% w/v in distilled Water

Topical Induction : undiluted as supplied

Topical Challenge : undiluted as supplied and 75% v/v in distilled Water

The Test material produced a 0% (0/9) sensitisation rate and was classified as a non-ssensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk phrase is required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The Test material produced a 0% (0/9) sensitisation rate and was classified as a non-ssensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk phrase is required.