Tetracopper hexahydroxide sulphate

Endpoint summary

Description of key information

Skin irritation/corrosion

A study was performed to OECD 404 to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Eye irritation

A study was performed to OECD 405 to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental phase: 13 February 2002 and 16 February 2002. Report issue: 13 June 2002.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-10 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually in suspended cages
- Diet: Free access to food (Certified rabbit diet) was allowed throughout the study
- Water : Free access to mains drinking water was allowed throughout the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg. C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored accordingly.

Number of animals:

Three.

Details on study design:

TEST SITE
- Area of exposure: back of each rabbit
- Coverage: 2.5 cm x 2.5 cm patch
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours

Irritation parameter:

erythema score

Basis:

animal: 29, 31, 32

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

other: Additional time point

Remarks:

Assessment immediately after application was also made which is recorded as time '0'

Irritation parameter:

edema score

Basis:

animal: 29, 31, 32

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

other: Additional time point

Remarks:

Assessment immediately after application was also made which is recorded as time '0'

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal: 29, 31, 32

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

other: Additional time point

Remarks:

Assessment immediately after application was also made which is recorded as time '0'

Faint light blue coloured staining was noted at all treated skin sites one hour after patch removal and at one treated skin site at the 24-hour observation. The staining did not affect evaluation of skin responses.

No evidence of skin irritation was noted during the study.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following guidelines:

 

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)

 

• Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

 

Method

On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

 

A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

 

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.

 

Results

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

 

Conclusion

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

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:

experimental study

Adequacy of study:

key study

Study period:

Experimental Phase: 18 February 2002 to 23 February 2002. Report issue: 13 June 2002.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet & Water: Free access to mains drinking water and food (certified rabbit diet).
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12h continuous light (06:00 to 18:00) and 12h darkness

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye by gently pulling the lower lid away from the eyeball.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

Number of animals or in vitro replicates:

Three

Details on study design:

Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.

Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment using a numerical evaluation according to Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Irritation parameter:

cornea opacity score

Basis:

animal: 120, 121, 122

Time point:

other: 1h

Score:

ca. 0

Max. score:

80

Irritation parameter:

cornea opacity score

Basis:

animal: 120, 121, 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

80

Irritation parameter:

iris score

Basis:

animal: 120, 121, 122

Time point:

other: 1h

Score:

ca. 0

Max. score:

10

Irritation parameter:

iris score

Basis:

animal: 120, 121, 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

10

Irritation parameter:

conjunctivae score

Basis:

animal: 120

Time point:

other: 1 h

Score:

4

Max. score:

20

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 120

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal: 121

Time point:

other: 1 h

Score:

ca. 8

Max. score:

20

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 121

Time point:

24 h

Score:

ca. 2

Max. score:

20

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 121

Time point:

other: 48/72h

Score:

ca. 0

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal: 122

Time point:

other: 1 h

Score:

ca. 8

Max. score:

20

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

20

Irritation parameter:

chemosis score

Basis:

animal: 120

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal: 121

Time point:

other: 1 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal: 121

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal: 122

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal: 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal: 120

Time point:

other: 1h

Score:

ca. 0

Max. score:

4

Other effects:

No corneal or iridial effects were noted during the study.

Results

Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in the remaining treated eye one hour after treatment. Minimal conjunctival redness was noted in one treated eye at the 24-hour observation.

Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a maximum group mean score of 6. 7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following gudielines:

 

• OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987)

 

• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

 

Method

Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

 

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

 

 

Result

A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

 

Conclusion

The test material produced a maximum group mean score of 6.7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available