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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 163.81 of the Regulations for the Enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (Federal Register, Wednesday, June 25, 1975)
Deviations:
not specified
Principles of method if other than guideline:
- Short description of test conditions:
Administration by esophageal intubation
Sprague-Dawley rats

- Parameters analysed / observed:
All animals were observed closely for gross signs of systemic toxiclty and mortality at frequent intervals during the day of dosage, and at least twice daily thereafter for a total of 14 days. Gross necropsies were performed on the animals that died. At the end of the 14-day observation period the surviving rats were weighed, sacrificed by CO- inhalation and gross necropsies were performed. Statistical analysis of the mortality data was by the moving average method.
GLP compliance:
no
Remarks:
GLP not mandatory at this date
Test type:
up-and-down procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)
EC Number:
238-200-7
EC Name:
Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)
Cas Number:
14285-59-7
Molecular formula:
C32H16CoN8O12S4
IUPAC Name:
tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The test sample was administered by esophageal intubation to one group, composed of ten Sprague-Dawley (weight range for the male rats was 233 to 240 grams and for the female rats was 200 to 234 grams). The sample was administered as a 25% weight per volume solution in corn oil (Mazola) at a dosage level of 1.25 grams per kilogram of body weight. When the study was repeated, the test sample was administered by esophageal
intubation to one group, composed of five male and five female Sprague- Dawley (weight range for the male rats was 200 to 221 grams and- for the female rats was 150 to 180 grams). The test sample was administered as a 25% weight per volume solution in distilled water at a dosage level of 5.0 grams per kilogram of body weight.
Due to deaths which occurred at this dose, a complete LD50- on the test material was then carried out.
The test sample was administered by esophageal intubation to five groups,
each composed of five male and five female Sprague-Dawley (weight range for the male rats was 200 to 245 grams and for the female rats was 153 to 193 grams).
The sample was administered as a 25% w/v solution in distilled water at dosage levels of 0.464, 1.00, 2.15, 4.64 and 10.0 grams per kilogram of body weight.
Food was withheld from the rats for approximately 18 hours prior to dosage.
Food and water were available ad libitum. The animals were housed
under a 12-hour light/12-hour dark cycle. The rats were acclimated to the laboratory at least seven days prior to dosage.
The test sample was administered by esophageal intubation to one group, composed of ten male Sprague-Dawley (The weight range : 233 to 240 grams). The sample was administered as a 25% weight per volume solution in corn oil (Mazola) at a dosage level of 1.25 grams per kilogram of body weight.
When the study was repeated, the test sample was administered by esophageal intubation to one group, composed of five male and five female Sprague- Dawley (weight range for the male rats was 200 to 221 grams and- for the female rats was 150 to 180 grams). The test sample was administered as a 25% weight per volume solution in distilled water at a dosage level of 5.0 grams per kilogram of body weight.
Due to deaths which occurred at this dose, a complete LD50- on the test material was then carried out.
The test sample was administered by esophageal intubation to five groups, each composed of five male and five female Sprague-Dawley (weight range for the male rats was 200 to 245 grams and for the female rats was 153 to 193 grams).
The sample was administered as a 25% w/v solution in distilled water at dosage levels of 0.464, 1.00, 2.15, 4.64 and 10.0 grams per kilogram of body weight.
Food was withheld from the rats for approximately 18 hours prior to dosage.
Food and water were available ad libitum. The animals were housed under a 12-hour light/12-hour dark cycle. The rats were acclimated to the laboratory at least seven days prior to dosage.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Except for the first experiment (dose of 1.25 g/ kg bw) where the vehicle was corn oil
Details on oral exposure:
Administration by esophageal intubation.
1.25 g/ kg bw : The sample was administered as a 25% weight per volume solution in corn oil
5.0 g/ kg bw : The test sample was administered as a 25% weight per volume solution in distilled water
0.464, 1.00, 2.15, 4.64 and 10.0 g/ kg bw : The sample was administered as a 25% w/v solution in distilled water
Doses:
1.25 g/ kg bw : The sample was administered as a 25% weight per volume solution in corn oil
5.0 g/ kg bw : The test sample was administered as a 25% weight per volume solution in distilled water
0.464, 1.00, 2.15, 4.64 and 10.0 g/ kg bw : The sample was administered as a 25% w/v solution in distilled water
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
All animals were observed closely for gross signs of systemic toxiclty and mortality at frequent intervals during the day of dosage, and at least twice daily thereafter for a total of 14 days. Gross necropsies were performed on the animals that died. At the end of the 14-day observation period the surviving rats were weighed, sacrificed by CO- inhalation and gross necropsies were performed. Statistical analysis of the mortality data was by the moving average method.
Statistics:
Statistical analysis of the mortality data was by the moving average method.

Results and discussion

Preliminary study:
1.25 g/ kg bw : no mortality occurs for both sex
5 g/ kg bw: 2 males died and all five female rats died
Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
5 010 mg/kg bw
Remarks on result:
other:
Remarks:
With a confidence interval of 95%
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 810 mg/kg bw
Remarks on result:
other: With a confidence interval of 95%
Mortality:
Main study :
All animal died at the 10.0 g/kg dosage
2 female died at the 4.64 g/kg dosage
Clinical signs:
other: Males : 1.00 g/kg : all rats exhibited blue-colored stools and tails. From the eighth post-dosage day until the termination of the study all rats exhibited normal appearance and behavior. 2.15 g/kg and 4.64 g/kg : From the first post-dosage day until th
Gross pathology:
Please refer to the section "Clinical Signs"

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item has a oral LD50 of 6.81 g/kg in male rats and 5.01 g/kg in female rats. Under tests conditions, results are considered scientifically valid to support a non classification under GHS criteria.

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