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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
Study period:
August 27, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC; L251
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
EC Number:
942-100-5
Molecular formula:
Not applicable: UVCB substance
IUPAC Name:
Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Male (158 - 180 g)
- Diet (e.g. ad libitum): ad libitum untill 16 h before the administration

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
Single dose: 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 and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, negroscopy
Statistics:
ROSIELLO et al.: J. Tox. Environ. Health.: 3, 797 (1977)
The method is based on Maximum-Likelihood-method: BLISS: Q.J.Pharm. Protocol. : 11, 192 (1938)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
other: No clinical signs observed
Gross pathology:
No abnormalities observed

Any other information on results incl. tables

Table of results:

dosis (g/kg bw) sex dead animals symptomatic animals survivors
5.0  (male) 0 0 5
5.0  (female) 0 0 5

Weight table:

female # week
  0 1 2
1 182 185 184
2 185 192 193
3 190 186 189
4 186 189 188
5 188 189 190
male # week
  0 1 2
1 180 210 227
2 163 186 210
3 165 202 230
4 158 181 200
5 158 180 200

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 (male/female) > 5000 mg/kg bw
Executive summary:

The substance to be registered has been tested according to EU Method B.1. During the study ten rats have been used (5 male and 5 female) for testing a single dose of 5000 mg/kg bw. No deaths occurred during the test and no abnormalities were seen in autopsy. The test item has shown a LD50 > 5000 mg/kg bw.