Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

Adopted: 17th December 2001

Deviations:

no

Remarks:

There were no significant deviations from the Good Laboratory Practice Regulations

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium

EC Number:

237-998-4

EC Name:

Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium

Cas Number:

14154-42-8

Molecular formula:

C32H16AlClN8

IUPAC Name:

31h-phthalocyaninato(2-)-n29,n39,n31,n32]-chloro[29(sp-5-12)-aluminu; chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-,(SP-5-12)-Aluminum;CHLOROALUMINUM PHTHALOCYANINE;CHLORO(29H,31H-PHTHALOCYANINATO)ALUMINUM; CHLORO(PHTHALOCYANINATO)ALUMINIUM;ALUMINUM PHTHALOCYANINE CHLORIDE;PHTHALOCYANINE CHLOROALUMINUM; chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Number of Animals: 5
Sex: Female, nulliparous and non-pregnant.
Species/Strain: Rat/Sprague-Dawley derived, albino.
Age/Body Weight: Young adult (8-10 weeks)/166-197 grams at experimental start.
Source: Received from SAGE® Labs on June 6, 2018.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during fasting.

Details on oral exposure:

Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

five

Control animals:

not specified

Details on study design:

Selection of Animals
Prior to each dosing, experimentally naive rats were fasted overnight by removing the feed from their cages. During the fasting period, the rats were examined for health and weighed (initial). Five healthy, naive female rats (not previously tested) were selected for test.


Preparation of Test Substance
The test substance, as received, was a solid. The test substance was administered as a 30% w/w mixture in distilled water. Preliminary sample preparation assessments conducted by PSL indicated that mixtures in excess of 30% (i.e., 40-80%) were too viscous to be administered properly. Each preparation was mixed well prior to use.

Dosing
The prepared test substance was administered to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing.

Cage-Side Observations
The animals were observed for mortality, signs of gross toxicity, and behavioral changes approximately 30 minutes post-dosing, during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems,somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.

Body Weights
Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 or 8 and Day 14 (terminal) following dosing.

Necropsy
All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Statistics:

Statistical analysis was limited to the calculation of the mean density value for dosing.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Under the conditions of this study, the acute oral LD50 of C.I. Pigment Blue 79 is greater than 2000 mg/kg of body weight in female rats.

Clinical signs:

other: Five animal were observed no signs of intoxication, change of health, nor any other adverse reactions during 24 hours or 14-days observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 of C.I. Pigment Blue 79 is greater than 2000 mg/kg of body weight in female rats.