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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable well documented study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF test: In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Polychloro copper phthalocyanine
EC Number:
215-524-7
EC Name:
Polychloro copper phthalocyanine
Cas Number:
1328-53-6
IUPAC Name:
[1,2,3,4,8,9,10,11,15,16,17,18,22,23,25-pentadecachloro-5,26-dihydro-29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
Details on test material:
- Name of test material (as cited in study report): Heliogengrün 8720
- Analytical purity: 100 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Firma Gassner, SPF breeding, Ottobrunn, Germany
- Weight at study initiation: males ca. 163 g; females ca. 145 g
- Diet: Altromin-R (Altrogge, Lage/L.), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water solution containing CMC
Details on oral exposure:
Concentration of the test material in vehicle:
- 30 % (6400 and 3200 mg/kg bw),
- 16 % (1600 mg/kg bw),
- 2 % (200 mg/kg bw)

-Amount of test material applied per gavage:
- 21.3 ml/kg bw for 6400 mg/kg bw;
- 10.6 ml/kg bw for 3200 mg/kg bw.
- 10 ml/kg bw for 1600 mg/kg bw;
- 10 ml/kg bw for 200 mg/kg bw.
Doses:
200, 1600, 3200 and 6400 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed and examined for clinical signs of toxicity during the first hour following application, after 4 and 5 hours and further on day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14 after dosing.
- The body weights of the individual animals were gathered prior to application of the test material.
- Necropsy of survivors performed: Deceased animals and those sacrificed at the end of the observation period (on day 14 after dosing) were necropsied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
All animals survived, no mortality was observed.
Clinical signs:
other: Green feces were observed in all animals treated 24 hours after application of the test material. Dyspnea was observed in animals of the 1600 mg/kg bw group immediately after treatment, but was reversible.
Gross pathology:
No abnormality was found in the organs.

Applicant's summary and conclusion