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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
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.
EC Number:
908-081-2
IUPAC Name:
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.
Test material form:
solid: particulate/powder
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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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:
There were no signs of systemic toxicity. Blue-coloured staining of the fur, faeces and urine was noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

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).

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