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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 84/449/EEC; L251

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

942-100-5

Molecular formula:

Not applicable: UVCB substance

IUPAC Name:

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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

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

Administration / exposure

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)

Results and discussion

Effect levels

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.