[29H,31H-phthalocyaninetrisulphonyl trichloridato(2-)-N29,N30,N31,N32]copper

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study meets requirements of OECD 401, Directive 92/69/EEC, B.1 and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[29H,31H-phthalocyaninetrisulphonyl trichloridato(2-)-N29,N30,N31,N32]copper

EC Number:

248-236-5

EC Name:

[29H,31H-phthalocyaninetrisulphonyl trichloridato(2-)-N29,N30,N31,N32]copper

Cas Number:

27121-30-8

Molecular formula:

C32H13Cl3CuN8O6S3

IUPAC Name:

Copper, [29H,31H-phthalocyanine-C,C,C-trisulfonyl trichloridato(2-)-kN29,kN30,kN31,kN32]-

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, breeding colony, SPF-breed
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: male 173 g - 185 g (mean 177 g), female 168 g - 177 g (mean 170 g)
- Fasting period before study: approximately 16 hours before to 3-4 hours after treatment, access to water permitted
- Housing: in groups of five in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Altromin 1324) ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionized water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Amount of vehicle (if gavage): 10 mL/kg body weight (test item in vehicle administered)
- the test item was dissolved in deionized water and distributed homogenously by magnetic stirring. Stability and homogeneity of the solution was analytically approved for 4 h.

Doses:

2000 mg/kg body weight (corresponding to 830 mg/kg body weight of the substance which is subject to registration)

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- mortality/viability: during the first 30 minutes and approximately 1, 2, 4, and 6 h after administration on day 1 and twice daily (once on weekends) on days 2-14.
-- clinical signs: during the first 30 minutes and approximately 1, 2, 3 and 6 h after administration on day 1 and and twice daily (once on weekends) on days 2-14.
-- ody weights: prior to administration), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

None

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 830 mg/kg bw

Based on:

other: substanct subject to registration

Remarks on result:

other: content of the substance subject to registration in the test sample was 41.5%

Mortality:

no deaths

Clinical signs:

other: After applilcation squatting posture, stilted gait and irregular respiration were observed. 8 hours after administration all clinical signs were reversible. The feces were discoloured black up to day 2 of the study.

Gross pathology:

No macroscopically visible changes at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the findings in this study the test item and the substance subject to registration have not to be classified according to Regulation (EC) No 1272/2008.

Executive summary:

One group of five male HoeWISK (SPF71) rats and one group of five female HoeWISK (SPF71) rats were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (deionized water) at a concentration of 20 % (w/v) and administered at a volume dosage of 10 mL/kg bw.

 

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 4 and 6 hours after treatment on day 1 and twice daily during test days 2-14. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 4 and 6 hours after administration on test day 1 (with the clinical signs) and daily during days 2-14. Body weights were recorded prior to administration and on days 7 and 14. All animals were necropsied and examined macroscopically.

 

All animals survived until the end of the study period.

 

The following clinical signs were observed: squatting posture, stilted gait and irregular respiration. Eight hours after application all clinical signs were reversible. Additionally, black discolored feces were observed up to day two of the study.

 

No macroscopic findings were recorded for the animals at scheduled necropsy.

 

The median lethal dose of the test item after single oral administration to male and female rats, observed over a period of 14 days is:

 

LD50 (male/female rat): greater than 2000 mg/kg body weight

 

Due to the fact that the content of the substance which is subject of registration in the test sample was 41.5% and dose formulations were prepared without adjustment the maximum dose level tested was 830 mg/kg body weight. Thus the resulting median lethal dose is:

 

LD50 (male/female rat): greater than 830 mg/kg body weight