Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guidelines 406
GLP compliance:
yes
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: hartiey albino guinea pigs

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and Vehicle used at induction:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
Concentration of test material and vehicle used for each challenge:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
Challenge
Concentration / amount:
Concentration of test material and Vehicle used at induction:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
Concentration of test material and vehicle used for each challenge:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 6

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 6.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100%

Signs of irritation during induction:

No dermal irritation was observed following test article application.

Evidence of sensitisation of each challenge concentration: 100 % test material moistened with acetone 0/10

Other observations :

At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal irritation 24 hours after application. 48 hours after test material application, 1 animal exhibited a slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group.

Applicant's summary and conclusion