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

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1973

Materials and methods

Test guideline

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

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:

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

Administration / exposure

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.

Results and discussion

Effect levels

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.