Reaction mass of Copper,di-µ-iodotris[triphenylphosphine]di- and iodobis(triphenylphosphino)copper

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 404

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Iodo-tris(triphenylphosphine)copper(I)

EC Number:

454-330-9

EC Name:

Iodo-tris(triphenylphosphine)copper(I)

Cas Number:

15709-82-7

Molecular formula:

Hill formula: C54H45CuIP3 CAS formula: C54H45CuIP3

IUPAC Name:

Iodo-tris(triphenylphosphine)copper(I)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 219001
- Expiration date of the lot/batch: January 01 , 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, room temperature, closed container

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species/ Strain: Rabbits
breed: White New Zealanders (SPF Crl:NZW)
Rationale: The rabbit is the preferred species for acute dermal irritation/corrosion studies and is acceptable to regulatory authorities.
Sex: male
Supplier: Charles River Wiga GmbH, D-97320 Sulzfeld
Hygiene status upon supply: SPF
Acclimatisation: The animals 1 and 3 were housed 3 weeks and animal 2 was housed 7 days before administration to the housing conditions of the test facility. In this time no signs were observed which indicated illness or other injury.
Body weight in g: 2.468 at the start of the study to 2.582 at the conclusion of the study (average values)
Identification: cage labelling showing the animal number, study number, time of dosing

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: Tylose MH 1000 in deionisiertem Wasser

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

The test was carried out with three rabbits.

Approximately 24 hours before testing the fur on the backs of the animals was closely clipped over an area of approximately 4 x 5 cm on the left and right side of the spine. One area was used as control. Only animals with healthy intact skin were used.

0.5 g of the test item were moistened with a 0.5 % (m/v) solution of Tylose MH 1000 in deionised water, applied to the shaved skin area (approx. 2 x 3 cm) and covered with one layer of a gauze patch (2.5 x 3.5 cm). It was covered with aluminium foil (3 x 4 cm) which was held in contact with the skin by occlusive dressing (Elastoplast, Beiersdorf AG).
A gauze patch moistened with 0.5 ml of deionised water was applied to the control area in the same manner.

Administration was performed on February 11th, 2003, 7.57 - 8.09 a.m.

After an exposure period of 4 hours the patch was removed and the application area was rinsed with deionised water without altering the integrity of the epidermis.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Other effects:

No systemic effects.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal irritation/corrosion of the substance was tested in three albino rabbits. The test item was applied as the original substance after crushing with a pestle and mortar to a fine dust, at a single dose of 0.5 g to a shaved dorsal area of trunk and covered with a gauze patch and aluminium foil which was held in contact with the skin with an occlusive dressing.

Exposure was for 4 hours and then the administration area was rinsed with deionised water.

Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes,
24, 48, 72 hours after patch removal. The grading of skin reaction given in the mentioned
guideline was used for the evaluation of the dermal irritation.

Not any alterations of the skin at the administration area were observed.
None of the animals died or showed clinical signs during the course of testing.

Executive summary:

Not any alterations of the skin at the administration area were observed.