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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from test report
Qualifier:
according to guideline
Guideline:
other: OECD Guidelines 406 EEC B.6 method, Section 4.1.7, Maximization test according to Magnusson and Kligman.
Principles of method if other than guideline:
Data is from test report
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Route:
intradermal
Vehicle:
maize oil
Concentration / amount:
Concentration of test material and vehicle used at induction: SInce an irritating concentration could not be obtained during the preliminary stage, it was decided to pretreat the induction test site with 10% SODIUM LAURYL SULFATE solution in vaseline.
The following concentrations of test material were used at induction: (1st phase INTRADERMAL INJECTIONS)
1) FCA (Freund's complete adjuvant) 1:1 diluted with isotonic saline
2) RA3643 in maize oil (3% dilution)
3) 3% dilutio of RA3643 in maize oil and FCA/Saline 1:1 4)

After 1 week topical application of 30% RA3643 in vaseline
Concentration of test material and vehicle used for each challenge: Challenge treatment (14 days after induction) by topical application of a 30% dilution of RA3643 in vaseline and of vaseline alone.
Route:
intradermal
Vehicle:
maize oil
Concentration / amount:
Concentration of test material and vehicle used at induction: SInce an irritating concentration could not be obtained during the preliminary stage, it was decided to pretreat the induction test site with 10% SODIUM LAURYL SULFATE solution in vaseline.
The following concentrations of test material were used at induction: (1st phase INTRADERMAL INJECTIONS)
1) FCA (Freund's complete adjuvant) 1:1 diluted with isotonic saline
2) RA3643 in maize oil (3% dilution)
3) 3% dilutio of RA3643 in maize oil and FCA/Saline 1:1 4)

After 1 week topical application of 30% RA3643 in vaseline
Concentration of test material and vehicle used for each challenge: Challenge treatment (14 days after induction) by topical application of a 30% dilution of RA3643 in vaseline and of vaseline alone.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 6
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
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: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
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: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 6.0.

Maximum concentration not causing irritating effects in preliminary test: 30 %

Signs of irritation during induction:

The topical pretreatment with sodium lauryl sulphate induced slight erythema in the controls and test animals. After the 48-hour topical application of the patches loaded with vaseline only, slight signs of skin irritation were observed in the controls. In the test animals also sligth signs of skin irritation were observed after the 48-hour topical application of the 30% dilution test substance.

Evidence of sensitisation of each challenge concentration: Neither at 24 hours nor at 48 hours after the challenge treatment did the 30% test dilution in vaseline or Vaseline alone induced skin reactions in test animals and controls.

Other observations:

None of the test animals reacted positively. Therefore the test substance in considered NOT to be a SENSITIZER. Since clear and unequivocal results were obtained in this study, no need for further examination in an additional batch of test and control animals in required.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material shows no sensitization effect (negative result) in the New Zealand White rabbit maximisation test.
Executive summary:

The test material shows no sensitization effect (negative result) in the New Zealand White rabbit maximisation test.

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

The test material shows no sensitization effect (negative result) in the New Zealand White rabbit maximisation test.


Migrated from Short description of key information:
The test material shows no sensitization effect (negative result) in the New Zealand White rabbit maximisation test.

Justification for selection of skin sensitisation endpoint:
The test material shows no sensitization effect (negative result) in the New Zealand White rabbit maximisation test.

Justification for classification or non-classification

The chemical bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate is classified as Non-sensitizing based upon the maximization test conducted in rabbits.

Categories Display