Methanone, (2-chloro-5-iodophenyl)[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 August - 12 September 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

(3S)-3-[4-(2-chloro-5-iodobenzoyl)phenoxy]oxolane

EC Number:

619-598-5

Cas Number:

915095-87-3

Molecular formula:

C17 H14 Cl I O3

IUPAC Name:

(3S)-3-[4-(2-chloro-5-iodobenzoyl)phenoxy]oxolane

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): IN 78281
- Physical state: White powder
- Analytical purity: 100.1 %
- Lot/batch No.: 7889-058-10
- Supplier: Boehringer Ingelheim Pharmaceuticals
- Expiration date of the lot/batch: Dec 2006
- Stability under test conditions: Stability data on bulk test material was not provided by the Sponsor
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:

mouse

Strain:

CBA:J

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME 04609
- Age at study initiation: 10 weeks
- Weight at study initiation: 19-24 g

- Housing: the animals were group house (5 per cage) upon receipt in compliance with national Research Council "Guide for the Care and Use of Laboratory Animals". The room in which the animals were kept was documented in the study records. No other species were kept in the same room.

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days prior to the first dosing


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.2-27.8 °C
- Humidity (%): 30-48%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Study design: in vivo (LLNA)

Vehicle:

other: sterile saline

Concentration:

5%, 15%, 35%

No. of animals per dose:

5

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

positive

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

0.89

Test group / Remarks:

5%

Remarks on result:

other: negative

Results 2

Parameter:

SI

Value:

1.16

Test group / Remarks:

15%

Remarks on result:

other: negative

Results 3

Parameter:

SI

Value:

1.03

Test group / Remarks:

35%

Remarks on result:

other: negative

Any other information on results incl. tables

Group	Treatment	Dose	DPM (mean+-sem)	SI	Result
1	DMF	-	413 +- 56	-	negative
2	IN 78281	5 %	368 +- 34	0.89	negative
3	IN 78281	15 %	480 +- 80	1.16	negative
4	IN 78281	35 %	425 +- 66	1.03	negative
5	HCA	35 %	3442 +- 410	8.33	positive

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. to CLP

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Although concentrations of dosing formulations were not confirmed, treatment with IN00078281 at concentrations up to 35% did not result in an SI of 3 or greater. Therefore, based on the data from this study, IN00078281 is not considered to have skin sensitizing potential.