Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/CEE B.6 MAXIMISATION TEST
GLP compliance:
yes
Type of study:
other: not provided

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
5% IN OLEUM ARACHIDIS (INTRADERMAL)
40% IN VASELINE (EPIDERMAL)
Concentration of test material and vehicle used for each challenge:
40 % IN VASELINE
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
5% IN OLEUM ARACHIDIS (INTRADERMAL)
40% IN VASELINE (EPIDERMAL)
Concentration of test material and vehicle used for each challenge:
40 % IN VASELINE
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentrarion not causing irritating effects in prelim

Signs of irritation during induction:

None

Evidence of sensitisation of each challenge concentration:

None

Other observation:

TESTED ON ANIMALS NO EVRTHEMA REACTIONS WERE OBSERVED AT 1, 5, 10, 20, 30 AND 40 % TEST SUBSTANCE IN VASELINA

Applicant's summary and conclusion

Interpretation of results:
other: not classified