Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August form 9th to 28th, 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Direct Blue 199_Na

IUPAC Name:

Direct Blue 199_Na

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Females were fasted.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Remarks:

distilled

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Two groups of three female: three female were treated, followed by a further group of three females at the same dose level.

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical and mortality observations: monitored during the study.
- Necropsy of survivors performed: all animals were subjected to gross necropsy.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths recorded.

Clinical signs:

other: No signs of systemic toxicity were observed.

Gross pathology:

Kidneys of all the females appeared stained green; in one case dark liver was observed.

Any other information on results incl. tables

Individual Clinical observations and mortality data

Animal number	Effects noted
	Hours after dosing				Days after dosing
	½	1	2	4	1*	2*	3*	4	5	6	7	8	9	10	11	12	13	14
1 - 0	0	0	0	0 U	0 F U	0 F U	0 F U	0	0	0	0	0	0	0	0	0	0	0
1 - 1	0	0	0	0 U	0 F U	0 F U	0 F U	0	0	0	0	0	0	0	0	0	0	0
1 - 2	0	0	0	0 U	0 F U	0 F U	0 F U	0	0	0	0	0	0	0	0	0	0	0
2 - 0	0	0	0	0 U	0 F U	0 F U	0 F U	0	0	0	0	0	0	0	0	0	0	0
2 - 1	0	0	0	0	0 F U	0 F U	0 F U	0	0	0	0	0	0	0	0	0	0	0
2 - 2	0	0	0	0	0 F U	0 F U	0 F U	0	0	0	0	0	0	0	0	0	0	0

0 = no signs of systemic toxicity

F = Faeces stained blue

U = Urine stained blue

* = Bedding stained blue

Individual Bodyweights and bodyweight changes

Animal number	Bodyweight (g) at day			Bodyweight gain (g) during week
	Day 1	Day 7	Day 14	1	2
1 - 0	214	239	256	25	17
1 - 1	200	217	237	17	20
1 - 2	211	241	268	30	27
2 - 0	203	226	243	23	17
2 - 1	203	237	249	34	12
2 - 2	186	226	240	40	14

Individual Necropsy Findings

Animal number	Macroscopic observations
1-0	Kidneys: stained green
1-1	Liver: dark, Kidneys: stained green
1-2	Kidneys: stained green
2-0	Kidneys: stained green
2-1	Kidneys: stained green
2-2	Kidneys: stained green

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

The present study was carried out to assess acute toxicity following a single oral administration to rats of the test substance to Sprague-Dawley CD strain rats, according to OECD Guideline 423. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

At the end of the study period, there was no mortality and no signs of systemic toxicity. No significant macroscopic alterations were observed in any of the major organs of the examined animals. Under the test conditions, LD50 was estimated to be greater than 2000 mg/kg bw.

Conclusion

LD50 > 2000 mg/kg bw