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

Endpoint summary

Description of key information

LD50 (oral) > 2.000 mg/kg bw and

LD50 (dermal) > 2.000 mg/kg bw expected due to Read-Across on structural similar substances.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Considering the structural similarities of the substances "Reaction mass of Copper,di-µ-iodotris[triphenylphosphine]di- and iodobis(triphenylphosphino)copper" and "Iodotris(triphenylphosphino)copper" and the almost identical physical and chemical properties, especially molecular weights, partition coefficients and water solubilites, it can be expected that the substances will show quite similar behaviour with respect to the toxicological endpoints acute toxicity (oral / dermal).

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: OECD 423

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97320 Sulzfeld
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 214.3 g ± 6.8 g (3 .2 %)
- Fasting period before study: yes
- Housing: Makrolon® Type 3 cage
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days before randomisation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21,0 - 21,5
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % tylose MH 1000 in deionized water

Doses:

2.000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

All animals were examined for mortality, clinical signs and body weight gain. The pathological
alterations of organs were examined at the end of a 14-day observation period.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0

Clinical signs:

No substance-related toxicological findings.

Body weight:

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

Gross pathology:

No substance-related pathological findings.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

None of the animals died after a single oral administration of 2000 mg/kg bw.
The LD50 (oral, rat) is> 2.000 mg/kg bw.
Clinical symptoms were not observed during the course of investigation.
The body weight gain of the animals was not affected.
No pathological findings were observed.

Executive summary:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Considering the structural similarities of the substances "Reaction mass of Copper,di-µ-iodotris[triphenylphosphine]di- and iodobis(triphenylphosphino)copper" and "Iodotris(triphenylphosphino)copper" and the almost identical physical and chemical properties, especially molecular weights, partition coefficients and water solubilites, it can be expected that the substances will show quite similar behaviour with respect to the toxicological endpoints acute toxicity (oral / dermal).

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: OECD 402

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

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

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Considering results of the structural similar compounds Iodo(triphenylphosphino)copper and Iodotris(triphenylphosphino)copper:

" Reaction mass of Copper,di-µ-iodotris[triphenylphosphine]di- and iodobis(triphenylphosphino)copper" has not to be classified as "acute toxic" for the exposure routes "oral" and "dermal", since the classification criteria according to (EU) No. 1272/2008 are not fulfilled.