Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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 OECD guideline 404.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2970 - 3185 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 45-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 0.5% (m/v) solution of Tylose MH 1000 in deionised water
Controls:
other: control site at the same animal
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24, 48 and 72 hours
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: approx. 2 x 3 cm, covered with one layer of a gaze patch (2.5 x 3.5 cm) and with aluminium foil (4 x 5 cm)
REMOVAL OF TEST SUBSTANCE
- cleaned with deionised water without altering the existing response or the integrity of the epidermis

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
The control skin areas did not show any irritations at any observation time.
The treated skin areas did not show any irritations at any observation time after all exposure periods, too.
Other effects:
No systemic toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with the results of this study and in compliance with the criteria of Appendix 6 to Directi ve 2001 /59/EU of August 06, 2001 P2 may beclassified as a substance that is non-irritant to the skin.
Executive summary:

In none of the animals treated with the substance any kind of skin alteration indicating irritating potential was present and none of the animals died during the course of the study. Also no clinical signs were noted and hence the substance is considered to be not irritating and is not classified.