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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Polychloro copper phthalocyanine
EC Number:
215-524-7
EC Name:
Polychloro copper phthalocyanine
Cas Number:
1328-53-6
Molecular formula:
C32HxClyCuN8
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
Test material form:
solid
Specific details on test material used for the study:
- Analytical purity: ca. 98 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: males: 180 g; females 160 g
- Fasting period before study: 15 to 20 hours prior to application
- Diet: Herilan MRH-Haltung (H. Eggersmann KG), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: suspension containing 0.5 % CMC and 1-2 drops Cremophor EL
Details on oral exposure:
- Concentration of the test material in vehicle: 50 %
- Amount of test material applied per gavage: 10 ml/kg bw
Doses:
5000 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 at 15 min, 30 min and 60 min, after 2, 4 and 5 hours and further on day 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14 after dosing.
- The body weights of the individual animals were gathered prior to application of the test material and on day 3, 7 and 13 after dosing.
- 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:
discriminating dose
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived, no mortality was observed.
Clinical signs:
other: Dyspnea, apathy, green feces as well as a poor general state were observed.
Gross pathology:
Autopsy revealed no relevant findings.

Any other information on results incl. tables

Table 1: Mean body weight (g) of rats after oral application of the test substance

 

Males

Females

Dose level [mg/kg bw]

5000

5000

Day 2-4

213

187

Day 7

237

198

Day 13

266

173

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met