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

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Test material form:

solid: crystalline

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.