Reaction mass of 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper and Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (dimethylamino)methyl derivs.

Endpoint summary

Description of key information

Acute toxicity: Oral:

The acute oral median lethal dose (LD50) of the test material: estimated to be greater than 2500 mg/kg bodyweight.                                                                                                                     

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 August 2005 - 05 September 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Description: blue powder
Batch number: 050708
Date received: 21 July 2005
Storage conditions: room temperature in the dark

Species:

rat

Strain:

other: Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 203 - 254
- Fasting period before study: overnight fast immediately before dosing and for approximate.ly three to four hours after dosing
- Housing: suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
- Enrichment: items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat. (total fraction)

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity. Blue-coloured staining of the fur, faeces and urine was noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight (GHS Category 5 >2000 - 5000 mg/kg bodyweight).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

According to TG and GLP.

Justification for classification or non-classification

Acute toxicity: Oral:

According to the GHS, it is a Category 5 as LD ₅₀ of the test material >2000-5000 mg/kg bodyweight.