Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted in compliance with GLP and according to the EU method B.6 (skin sensitisation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-1,4-bis(iodomethyl)cyclohexane
Cas Number:
83447-96-5
Molecular formula:
C8H14I2
IUPAC Name:
trans-1,4-bis(iodomethyl)cyclohexane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 days
- Weight at study initiation: 370.1 g +/- 18.5 g (n=15)
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 0.5% (w/v) solution of Tylose MH 1000 in deionised water
Concentration / amount:
A 5 % (w/v) suspension of the test item in a sterile 0.5 % (w/v) solution of Tylose MH 1000 in deionised water was used for intracutaneous induction.
A 25 % (w/w) mixture of the test item with vaseline was used for epicutaneous induction and for the challenge on day 21 , too.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 0.5% (w/v) solution of Tylose MH 1000 in deionised water
Concentration / amount:
A 5 % (w/v) suspension of the test item in a sterile 0.5 % (w/v) solution of Tylose MH 1000 in deionised water was used for intracutaneous induction.
A 25 % (w/w) mixture of the test item with vaseline was used for epicutaneous induction and for the challenge on day 21 , too.
No. of animals per dose:
Pilot study: 2 animals
Main study: 5 animals for the control group and 10 animals for the dose group
Details on study design:
The aim of the pilot study was to find out the highest concentrations which cause mild-to-moderate skin irritation after intracutaneous and
epicutaneous administration and the highest non-irritant concentration after epicutaneous administration.

Results and discussion

Positive control results:
The positive control animals used as reference were not part of this study and the data were generated in October/November 2003. The data attached to the report showed a positive response in all animals clearly indicating the expected response of the test system.

In vivo (non-LLNA)

Results
Reading:
other: see table below
Remarks on result:
other: Reading: other: see table below.

Any other information on results incl. tables

Skin Reactions, Individual Data

left flank:control; right flank: test item

Testgroup

AnimaI

No.

Day1

Day7

Day9

Day 23

Day24

left

right

left

right

left

right

left

right

left

right

Control

group

1

1/  E2S

2/ 0

3/ EI S

1/ E2S

2/ 0

3/ E2S

E2

E2

0

0

0

0

0

0

2

1/ E2S

2/  0

3/ E2S

1/ E2S

2/ 0

3/ E2S

E2

E2

0

0

0

0

0

0

3

11 E2S

2/  0

3/ EI S

1/ E2S

2/ 0

3/  E2S

E2

El

0

0

0

0

0

0

4

1/ E2S

2/ 0

3/ E2S

1/ E2S

2/  0

3/ E2S

E2

E2

0

0

0

0

0

0

5

1/  EI S

2/ 0

3/ EI  S

1/ E2S

2/  0

3/  EI  S

E2

El

0

0

0

0

0

0

Dose

group

6

1 / E2S

2/ s

3/ EIS

1/ E2S

2/  0

3/  EI S

E2

E2

0

0

0

0

0

0

7

II E2S

2/  s

3/  EI S

1/ EI S

2/ 0

3/  EI  S

E2

El

0

0

0

0

0

0

8

I I E2S

2/ s

3/ E2S

1 / E2S

2/  s

31 EI S

EI

E2

0

0

0

0

0

0

9

1/ E2S

2/ s

3/ EI  S

1 / E2S

2/  s

3/  E2S

E2

E2

0

0

0

0

0

0

10

1/ E2S

2/ s

3/  E2S

1 /  E2 S

2/  s

3/ EI  S

E2

E2

0

0

0

0

0

0

11

1/ E2S

21s

31E2S

1/ E2S

2/ s

3/  E2S

E2

E2

0

0

0

0

0

0

12

1/E2S

21s

,31 E2S

1/ E2S

2/  s

3/  EI S

E2

El

0

0

0

0

0

0

13

1/ E2S

21s

31E2S

1/ E2S

2/  0

3/  EI S

E2

E2

0

0

0

0

0

0

14

1/ E2S

2/  s

3/ E2S

1 / E2S

2/  s

3/  EI  S

E1

E2

0

0

0

0

0

0

15

1/ EI S

2/  0

31EI S

1 / E2S

2/  s

3/  EI S

E2

E2

0

0

0

0

0

0

1/ injection site cranial

2/ injection site medial

3/  injection site cauclal

 

E=Erythema grade        S= slight Oedema                           0=no skin reaction

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the classification system for skin reactions of the Appendix 6 to Directive 2001 /59/EU P2 is not to c1assify as skin sensitiser accordingto the results of this sensitisation study.