Iodo(triphenylphosphino)copper

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species / Strain: rat/ Wistar Crl:WI BR
Rationale: The rat is a suitable rodent species for acute toxicity studies and is acceptable to regulatory authorities.
Sex: male, female (nulliparous, non-pregnant)
Supplier: Charles River Wiga GmbH, D-97320 Sulzfeld
Hygiene status upon supply: SPF
Age at start of acclimatisation: approximately 4 weeks
Acclimatisation: The animals were housed 4 weeks before administration to the housing conditions of the test facility. In this time no signs were observed which indicate an illness or other injury.
Randomisation: Animals were assigned to cages according random numbers one day prior to administration.
Mean body weight at administration:
Males: 294.0 g ± 17.7 g (6.0 %) n = 5
Females: 208.8 g ± 18.5 g (8.8 %) n = 5
Identification: Ear notches and cage labelling showing the animal number, study number, dose, sex, time of dosing and end of observation period.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Tylose MH 1000 in deionisiertem Wasser. "ENGLISH" Tylose MH 1000 in deionized water.

Details on dermal exposure:

Route of administration: dermal
Preparation of animals: Approximately 24 hours before administration the fur was removed by shaving from the dorsal area (6x6 cm) of the trunk. Only animals with healthy intact skin were used.
Administration amount: 0.2 g/100 g body weight; Individual doses were adjusted according to the recorded body weight.
Form of administration: The test item was moistened with a 0.5 % (m/v) solution of Tylose MH 1000 in deionised water, applied to the shaved skin area and covered with a layer of a gaze patch and then with aluminium foil (6.5 x 6.5 cm). This patch was held in contact with the skin by occlusive dressing (Elastoplast, Beiersdorf AG).
Time of administration: single administration on May 06, 2003, 7.08 - 7.38 a.m.
Exposure period: After 24 hours the patch was removed and the application area was cleaned with deionised water without altering the integrity of the epidermis.

Duration of exposure:

24 h

Doses:

2.000 mg/kg bw

No. of animals per sex per dose:

10 (5 males / 5 females)

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

None of the animals showed alterations of the general state of well-being during the course of investigation.

Body weight:

The body weight gain of the animals was not affected by the administration of the test item.

Gross pathology:

There were no macroscopic pathological findings in the animals.

Other findings:

No substance-related local effects.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 (dermal, rat) is > 2.000 mg/kg bw.

Executive summary:

Acute dermal toxicity of the substance was tested in 5 male and 5 female Charles River Wistar rats. The test item was applied at a single dose of 2000 mg/kg body weight to a shaved dorsal area of the trunk of the animals and was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. Exposure was for 24 hours.

Animals were examined for mortality, clinical signs, alterations of the administration area, body

weight gain and pathological alterations of organs at the end of a 14-day observation period.

None of the animals died during the course of the investigation.

The LD50 (dermal, rat) is > 2.000 mg/kg bw.

Clinical signs were not observed during the observation period.

The body weight gain of the animals was not affected by the test item.

No pathological findings were observed at necropsy.