Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate

Endpoint summary

Description of key information

LD50 (oral) > 5000 mg/kg bw, 
LC50 (inhalation) > 179 mg/kg bw, 
LD50 (dermal) > 2025 mg/kg bw.

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:

August 27, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: 84/449/EEC; L251

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Male (158 - 180 g)
- Diet (e.g. ad libitum): ad libitum untill 16 h before the administration

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

Single dose: 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, negroscopy

Statistics:

ROSIELLO et al.: J. Tox. Environ. Health.: 3, 797 (1977)
The method is based on Maximum-Likelihood-method: BLISS: Q.J.Pharm. Protocol. : 11, 192 (1938)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: No clinical signs observed

Gross pathology:

No abnormalities observed

Table of results:

dosis (g/kg bw)	sex	dead animals	symptomatic animals	survivors
5.0	(male)	0	0	5
5.0	(female)	0	0	5

Weight table:

female #	week
	0	1	2
1	182	185	184
2	185	192	193
3	190	186	189
4	186	189	188
5	188	189	190
male #	week
	0	1	2
1	180	210	227
2	163	186	210
3	165	202	230
4	158	181	200
5	158	180	200

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 (male/female) > 5000 mg/kg bw

Executive summary:

The substance to be registered has been tested according to EU Method B.1. During the study ten rats have been used (5 male and 5 female) for testing a single dose of 5000 mg/kg bw. No deaths occurred during the test and no abnormalities were seen in autopsy. The test item has shown a LD50 > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

According to internationally accepted testing guidance

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 22, 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not applicable

GLP compliance:

no

Remarks:

Pre GLP.

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ARS/Sprague - Dawley, Madison, Winsconsin
- Age at study initiation:
- Weight at study initiation: 153 g
- Fasting period before study: fasted during exposition
- Housing: individually in stock cages
- Diet (e.g. ad libitum): standard laboratory diet with Purina Rat Chow, Ralston Purina Company, St. louis, Missouri
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass inhalation chamber
- Exposure chamber volume: 70 liters
- Method of holding animals in test chamber:
- Source and rate of air: Dust feeder, rate of air: 6.4 L/min
- Method of particle size determination: microscopic determination
- Temperature, humidity, pressure in air chamber: 25 °C, 29.92 inches Hg

TEST ATMOSPHERE
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 1 - 5 microns : 34%; 6 - 25 microns: 58%; 26 - 615 microns: 8%

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

179 mg/m3 air

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 179 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No deaths occurred

Clinical signs:

other: No evidence

Body weight:

Within the normal limits, average two-week body weight gain was 57g

Gross pathology:

Minimal to mild focal red discoloration of the lungs in all rats

Other findings:

No untoward behavioral reactions

Particle Size Distribution data:

Particle size range (microns)	N. of Particles counted	% of total counted
1 - 5	152	34
6 - 25	263	58
26 - 615	35	8

Conclusions:

LC50 (male/female) > 179 mg/m3 air

Executive summary:

The substance to be registered has been tested according a procedure similar to OECD 403. During the study the concentration of 179 mg/m³ air has been tested on ten rats (5 male and 5 female). After the 14 days observation period there were no deaths, no untoward behavioural reactions or adverse body weight effect. Necroscopy revealed minimal to mild red discoloration in the lungs of all rats. In these experimental conditions the test substance has shown a LC50 > 179 mg/m³ air.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

179 mg/m³ air

Quality of whole database:

Method equivalent or similar to guidelines internationally accepted.

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:

February 26, 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

Principles of method if other than guideline:

Number of animals: 4 rabbits (2 male and 2 female)

GLP compliance:

no

Remarks:

Pre GLP.

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

other: New Zeland

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.94 - 3.2 g
- Housing: individually in suspende, wire - bottomed cagesand maintained on a standard laboratory ration
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- % coverage: 30%
- Type of wrap if used: plastic wraptaped in place

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

Duration of exposure:

24 h

Doses:

2025 mg/kg bw

No. of animals per sex per dose:

2 male and 2 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Initial and final body weight recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behavioral abnormalities.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 025 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: No untoward behavioral reactions were noted

Gross pathology:

No gross pathologic alterations revealed

Other findings:

A bright blue stain noted at the 24h, 7d and 14d observations

Mortality and body weight data:

dose mg/kg bw	animal		individual body weight		n° dead/ n°tested	% dead
	n°	sex	day n° 0	day n° 14
2025	1	m	3.2	3.24	0/4	0
	2	m	2.94	2.6
	3	f	3.2	3.2
	4	f	3.2	3.24

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 (male/female) > 2025 mg/kg bw

Executive summary:

The substance to be registered has been tested according a procedure similar to OECD 402, during the study the single dose 2025 mg/kg bw has been tested on 4 rabbits (2 male and 2 female). After the 14 days observation period there were no deaths , untoward behavioral reactions or adverse body weight effect. A bright blue stain was noted at the contact site at 24h, 7d, 14d observations. Necroscopy revealed no gross pathologic alterations among any animals. In these experimental conditions the test item shows a LD50 > 2025 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 025 mg/kg bw

Quality of whole database:

Method equivalent or similar to guidelines internationally accepted.

Additional information

A study on intraperitoneal acute toxicity was conducted in 1982 but only a short summary is available. During the study, the test substance showed a high value for median lethal dose (LD50 = 1790 mg/kg bw).

Justification for classification or non-classification

According to the CLP Regulation (EC) n. 1272/2008 Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The test subsatnce is not classified according to tables 3.1.1 and 3.1.2 of the CLP Regulation.