Iodo(triphenylphosphino)copper

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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 "Iodo(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 skin irritating properties.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: OECD 404

GLP compliance:

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:

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

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.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

No systemic effects.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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 "Iodo(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 eye irritating properties.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: OECD 405

GLP compliance:

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:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species / Strain: Rabbits
breed: White New Zealanders (SPF Crl:NZW)
Rationale: The rabbit is the preferred species for acute eye 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 were housed 3 weeks 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: 2.878 at the start of the study to 2.977 at the conclusion of the study (average values)
Identification: cage labelling showing the animal number, study number, time of dosing

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

The test was carried out with three rabbits.

Both eyes of each animal were examined approximately 24 hours before testing. Two to three drops of a fluorescein sodium solution (0.5 % in deionised water) were instilled into the conjunctival sac and rinsed out again after 30 sec with deionised water. No ocular defects were observed in any of the animals.

0.1 g of the test item were instilled into the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for some seconds in order to prevent loss of the material.

The other eye of the same animal, which remained untreated, served as control.

Administration was performed on February 11th, 2003 , 7.46 - 7.49 a.m.

After an exposure period of 24 hours the treated eyes were rinsed out with deionised water carefully.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 2 days

Other effects:

No systemic effects.

Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not irritating

Executive summary:

The acute eye irritation/corrosion of the substance was tested in three albino rabbits.

The test item was instilled as the original substance after crushing with a pestle and mortar to a fine dust at a single dose of 0.1 g to one of the eyes in each animal. The untreated eye was used for control.

The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48 and 72 hours after instillation of the test item. The grades for ocular lesions were recorded in accordance with the mentioned guideline.

The instillation of the test item caused a slight redness of the conjunctivae in all animals and a slight swelling of the conjunctivae in one animal on the day of instillation. A slight redness of the conjunctivae was observed in one animal one day thereafter too.

The cornea and the iris were not affected.

48 hours after instillation no signs of irritations were observed.

None of the animals died or showed clinical signs during the course of testing.

The alterations of the eyes after instillation of the substance do not meet the criteria for

classification of a substance as an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Considering the results of the structural similar compound Iodotris(triphenylphosphino)copper,

Iodo(triphenylphosphino)copper has not to be classified as "irritating" to skin or eye, since the classification criteria according to (EU) No. 1272/2008 are not fulfilled.

Additionally, tests on irritation to skin or eye, conducted with Iodo(triphenylphosphino)copper itself - though not under GLP conditions - suggest that the classification criteria according to (EU) No. 1272/2008 are not fulfilled.