Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test.
Title:
Unnamed
Year:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.6
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Migrated from NONS file.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-450-9
EC Name:
-
Cas Number:
294-90-6
Molecular formula:
C8H20N4
IUPAC Name:
1,4,7,10-tetraazacyclododecane
Test material form:
not specified
Details on test material:
- Substance name: 1,4,7,10-tetraazacyclododecane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan

Study design: in vivo (non-LLNA)

Induction
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
20% test substance in 1% aqueous carboxylmethyl cellulose
Challenge
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
5% test substance in 1% aqueous carboxylmethyl cellulose
No. of animals per dose:
Number of animals in test group: 10Number of animals in negative control group: 5
Challenge controls:
Negative challengue controls

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 20 %.

Signs of irritation during induction:

  • Erythema (24 h) and necrosis (24 and 48 h)after injection.
  • Erythema in 2 treated animals (day 10).

Evidence of sensitisation of each challenge concentration:

No evidence of sensitization.

Other observations:

None

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Migrated information criteria used for interpretation of results: EU
Conclusions:
The test substance was not classified as a sensitisation agent.
Executive summary:

A skin sensitization test was performed according to OECD guideline 406 and 92/69/EWG, B.6 Guideline under GLP conditions.

 

Himalayan guinea pigs were administered with test substance using CMC as a vehicle (20% test substance in 1% aqueous CMC for test subjects and 5% test substance in 1% aqueous CMC for the challenge group). Readings were performed 24 and 48h after injection.

 

The results provided evidence that the test substance did not cause any irritating effects hence, the test substance is not classified as a skin sensitizer agent.