Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfonated

Endpoint summary

Description of key information

Acute oral: Acute oral study using OECD 423, resulted in LD50 >2000 mg/kg of body weight (females). Substance is not classified as acute oral toxic according CLP criteria (regulation (EC) No. 1272/2008).

Acute dermal: Based on the results of this study using OECD 402, the LD50 > 2000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.

Acute inhalation: WAIVER

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19. 8. - 3. 9. 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study from supporting substance (structural analogue)

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 - 12 weeks at the time application
- Weight at study initiation:
- Fasting period before study:
- Housing: animal room with monitoring conditions - 3 animals in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): ST1 BERGMAN- standard pellet diet ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2013-08-19 To: 2013-09-03

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
-Aqua pro injectione
Batch No. 0101050612
Expiration: 06/2014
Manufacturer: ARDEAPHARMA a. s., Ševětín, Czech republic

MAXIMUM DOSE VOLUME APPLIED: 2 ml

DOSAGE PREPARATION (if unusual):
Immediately before application the test substance was weighed, mixed in water and resulting solution was administred to the stomach by tube.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test 2000 mg/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

Step 1: 3 females
Step 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
weighing: before administration, 8th day, 15 th day (before euthanasia)
observation: first day twice (30 min and 3 hr after administration)
second day twice (in the morning and in the afternoon)
daily thereafter for 14 days

- Necropsy of survivors performed: yes/no
All test animals survived to the end of study were sacrificed on the 15 th day by injection of veterinary preparation T61 (1 ml iv.) and gross necropsy was
carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: No clinical signs of intoxication were observed during the study.

Gross pathology:

Without pathological changes in both steps.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral study using OECD 423, resulted in LD50 >2000 mg/kg of body weight (females). Substance is not classified as acute oral toxic according CLP criteria (regulation (EC) No. 1272/2008).

Executive summary:

Acute oral: Acute oral study using OECD 423, resulted in LD50 >2000 mg/kg of body weight (females). Substance is not classified as acute oral toxic according CLP criteria (regulation (EC) No. 1272/2008).

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:

experimental study

Adequacy of study:

key study

Study period:

22 March 2017 to 12 April 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

Quality Assurance Statement

Test type:

standard acute method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

One group of 5 male and 5 female rats. Upon arrival, all animals were housed individually in clean, wire-mesh cages. The animals were maintained by the animal husbandry staff of Charles River in accordance with SOPs. Animals were maintained in accordance with the Guide for the Care and Use of Laboratory Animals.2 The animal facilities at Charles River Ashland are accredited by AAALAC International. Enrichment devices were provided to all animals as appropriate throughout the study for environmental enrichment and to aid in maintaining the animals’ oral health, and were sanitized weekly.
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: [yes] 5
- Males: 5
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 to 350 g (males)/150 to 300 g (females)
- Fasting period before study: No
- Housing: All animals will be individually housed following receipt in clean, wire-mesh cages in an environmentally controlled room. The cages will be cleaned and changed routinely at a frequency consistent with maintaining good animal health.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C to 26°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): a minimum of 10 room air changes per hour, 100% fresh air.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark photoperiod

IN-LIFE DATES: From: To: 23 March 2017 to 12 April 2017

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs and flanks
- % coverage: 10%
- Type of wrap if used: 4-ply gauze pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): bandages were removed and the sites were wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 50 mg/kg
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Lot/batch no. (if required): 1941172044
- Purity: 100%

Duration of exposure:

24 hours

Doses:

1

No. of animals per sex per dose:

5 animals per sex per dose (male and female)

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 14 days (the observation period may be extended if signs of systemic toxicity are present)
- Frequency of observations and weighing: Study Days 0, 7, and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs/observations, dermal observations, body weight, other: A gross necropsy examination on major organ systems of the cranial, thoracic and abdominal cavities will be conducted on all animals found dead, euthanized in extremis or euthanized at termination.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality.

Clinical signs:

other: No significant clinical observations.

Gross pathology:

At the scheduled necropsy, macroscopic findings consisted of blue discolouration of the tail for 4 males and all females. Blue discolouration was observed at the application site for 1 female. The discolouration findings were expected based on the colour of test material and were not considered adverse.

See tables attached in the background section below for final report findings.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the LD50 of the test material was greater than 2000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.

Executive summary:

Based on the results of this study using OECD 402, the LD50 of the test material was greater than 2000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

In accordance with Regulation EC 1272/2008, the registered substance is not classified for acute toxicity via the dermal and oral route. The acute oral toxicity of the registered substance was determined to be > 2000 mg/kg bw via the oral and dermal route.