trans-1,4-bis(iodomethyl)cyclohexane

Skin sensitisation

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

Test material information

Constituent 1

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)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: 0.5% (w/v) solution of Tylose MH 1000 in deionised water

Induction 2

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.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: 0.5% (w/v) solution of Tylose MH 1000 in deionised water

Challenge 2

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.