Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Information from migrated NONS file, as per inquiry number 06-2120017060-79-0000, permission to refer granted by ECHA
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Maximisation test according to Magnusson and Kligman

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
421-450-8
EC Name:
-
Cas Number:
154702-15-5
Molecular formula:
C44H59N7O5
IUPAC Name:
2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate

In vivo test system

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: maize oil, Freund's complete adjuvant/saline, vaseline
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 :
1) FCA (Freund's complete adjuvant) diluted with isotonic saline (1:1)
2) 3% test substance in maize oil
3) 3% test substance in maize oil and FCA/saline 1:1
4) After 1 week tpoical application of 30% test substance in vaseline

Concentration of test material and vehicle used for each challenge : Challenge treatment (14 days after induction) by topical application of a 30% test substance in vaseline and vaseline only.
Challengeopen allclose all
Route:
other: topical application
Vehicle:
other: maize oil, Freund's complete adjuvant/saline, vaseline
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 :
1) FCA (Freund's complete adjuvant) diluted with isotonic saline (1:1)
2) 3% test substance in maize oil
3) 3% test substance in maize oil and FCA/saline 1:1
4) After 1 week tpoical application of 30% test substance in vaseline

Concentration of test material and vehicle used for each challenge : Challenge treatment (14 days after induction) by topical application of a 30% test substance in vaseline and vaseline only.
No. of animals per dose:
Number of animals in test group : 10
Number of animals in negative control group : 6
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

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

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

Evidence of sensitisation of each challenge concentration : Neither at 24 hours nor at 48 hours after the challenge treatment did the 30% dilution of test substance in vaseline or vaseline alone induce skin reactions in test and control animals. None of the test animals reacted positively. The test substance is considered not to be a sensitiser.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not sensitising.