[No public or meaningful name is available]

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: techniques specified in the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR 163).

GLP compliance:

no

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Molecular formula:

C32H16N8Co(SO3)n with n=0 to 3

IUPAC Name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: weight range for the male rats was 200 to 257 grams and for the female rats was 200 to 230 grams.
- Diet (e.g. ad libitum): ad libidum
- Water (e.g. ad libitum): ad libidum
- Acclimation period: 6 day prior to dosing

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12hrs dark/ 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Except for one screening procedure which has been carried out with corn oil

Details on oral exposure:

Screening procedure in distilled water : The sample was administered as a 25.0% w/v solution in distilled water at a dosage level of 5.0 grams per kilogram of body weight.
Screening procedure in corn oil : rats was 237 to 261 grams and for the female rats was 217 to 238 grams. The sample was administered as a 25.0 % w/v solution in corn oil at a dosage level of 5.0 grams per kilogram of body weight.
Median lethal dosage determination in distilled water : The sample was administered as a 50,0% w/v solution in distilled water at dosage levels of 1.0, 2.0, 4.0, and 8.0 grams per kilogram of body weight.

Doses:

Screening procedure in distilled water : The sample was administered as a 25.0% w/v solution in distilled water at a dosage level of 5.0 grams per kilogram of body weight.
Screening procedure in corn oil : rats was 237 to 261 grams and for the female rats was 217 to 238 grams. The sample was administered as a 25.0 % w/v solution in corn oil at a dosage level of 5.0 grams per kilogram of body weight.
Median lethal dosage determination in distilled water : The sample was administered as a 50,0% w/v solution in distilled water at dosage levels of 1.0, 2.0, 4.0, and 8.0 grams per kilogram of body weight.

No. of animals per sex per dose:

5 per sex and per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
All animals were observed closely for gross signs of systemic toxicity and mortality at three-quarter to two and onequarter, three and one-quarter to four and one-half, and four and one-quarter to five and three-quarter hours during the day of dosing, and twice daily (except days 2 and 3) thereafter for a total of 14 days. The rats were not weighed individually on the seventh postdosing day in deviation from the protocol.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

3 700 mg/kg bw

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

3 600 mg/kg bw

Mortality:

5 g/kg, distilled water : all animals died
5 g/kg, corn oil : 7 animals died
1g/kg : no death
2 g/ kg : 1 female died
4 g/ kg : 3 males and 1 female died
8 g/kg : all animals died

Clinical signs:

other: nine females from the 1.0 and 4.0 g/kg dosage levels which showed sample colored diarrhea or feces.. Sample staining of the tail and/or anus was observed in most surviving male and female rats from all dosage groups. Central nervous system depression was

Gross pathology:

nine females from the 1.0 and 4.0 g/kg dosage levels which showed sample colored diarrhea or feces.. Sample staining of the tail and/or anus was observed in most surviving male and female rats from all dosage groups.
Central nervous system depression was observed at the two higher dosages in males and the highest level in females during the first week of the observation period.
Sporadic abnormalities noted in a few rats at the higher dosages (4.0 or 8.0 g/kg) included humped-back posture (male, female), piloerection (male, female), slight emaciation (male), nasal discharge (male),
comatose behavior (male), decreased locomotor activity (female), and squinted eyes (female).

Necropsies of all eight males and most of the seven females revealed stomachs and intestines which were either sample stained or contained sample-colored contents. An external abnormality observed in most animals was sample staining of the fur over most of the body including extre.mifcies, mouths, and anuses. Diarrhea stains around the anuses of three females and one male were noted. Two male rats appeared cannibalized by the time of necropsy. Bloated stomachs were observed in four males and two females. Autolysis was noted in three males and two females. Most rats of either sex had congested or darkened kidneys and several had pale livers.

One male and one female rat (2.0 g/kg level) exhibited hollow right and/or left kidneys. The same female rat had a growth on the right kidney, which was not considered drug-related.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the tests conditions, the test item has a oral LD50 of 3.6 g/kg in male rats and 3.7 g/kg female rats. According to GHS criteria, the test item is classified as Acute toxicity oral category 5.