(S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC B6 Buhler test.

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

At the time of testing LLNA was not validated

Test material

Test material information

1

Reference substance name:

(S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene

EC Number:

410-940-7

EC Name:

(S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene

Cas Number:

60166-91-8

Molecular formula:

C13H8Cl2I3NO5

IUPAC Name:

1-{[3,5-bis(carbonochloridoyl)-2,4,6-triiodophenyl]carbamoyl}ethyl acetate

Test material form:

solid: particulate/powder

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals and environmental conditions:

The Dunkin Hartley albino guinea pig is the species generally recommended by the Health Authorities as the experimental model for skin sensitization studies

Supplier:
Charles River Italia S.p.A.
Via Indipendenza, 11
22050 Calco (Como)

Number:
37 animals
20 animals in the experimental group
10 animals in the negative control group
7 animals for the preliminary test

Body weight (and age):
between 436-509 g at the start of the experiment (corresponding to an age of 6 weeks)

Sex: males

Acclimattion: 10 days

Housing:
(room H12C)
2 or 3 animals/cage in an air-conditioned room.
- temperature: 22 ± 2 ° C
- air changes: about 20/h filtered on HEPA 99.97% filtres
- relative humidity: 55 ± 10%
- artificial light: 12 h cycle (7 a.m. - 7 p.m.)
- cage: wire cages (40.5x38.5x18h) with a stainless steel feeder.
The waste that dropped through the wire bottom onto removable paper was periodically disposed of.

Study design: in vivo (non-LLNA)

Induction

Concentration / amount:

Concentration of test material and vehicle used at induction:
a) Test substance 50% in acetone

b) Vehicle - acetone 100%

Concentration of test material and vehicle used for each challenge:
a) 50% test substance in acetone

b) 100% vehicle - acetone

Challenge

Concentration / amount:

Concentration of test material and vehicle used at induction:
a) Test substance 50% in acetone

b) Vehicle - acetone 100%

Concentration of test material and vehicle used for each challenge:
a) 50% test substance in acetone

b) 100% vehicle - acetone

No. of animals per dose:

Number of animals in test group: 20
Number of animals in negative control group: 20

Details on study design:

two preliminary tests were performed on March 3 and 10,1992 (shipping slips no.s 01301, 01598 and 02038 dated February 12, 21 and March 6, 1992, respectively) in order to select the maximum well tolerated concentration for the induction phase and the maximum concentration shown to be not irritating for the challenge exposure.
In the first test concentrations of 25%, 10% and 5% were assayed on three animals.
An aliquot of 0.5 ml of each test article concentration was applied to the skin of two animals with a closed patch.
Twenty-four hours after the administration, the patches were removed, and the animals observed for up to 48 h for local reactions on the skin area of the patch application. The concentrations assayed were well tolerated and not irritating.
On the basis of these results, a second test was performed using two higher concentrations, 50% and 35%, on 4 animals in order to find a possible moderate irritation. Concentrations of 50% and 35% were once more shown to be tolerated and not irritating. A concentration of 50% (w/v) was therefore used in the final test.

he test article was solubilized in acetone to obtain a 50% (w/v) test article concentration (maximum practicable concentration).
The test article formulate was prepared just before use, and protected from light (plastic tube wrapped in aluminium sheet).
Due to the type of study, analysis for stability and concentration was not performed.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

6

Group:

test chemical

Dose level:

50 %

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
None

Other observations:
None.

Applicant's summary and conclusion

Interpretation of results:

other: not classified