Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 26 to August 15, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

224-460-9

EC Name:

Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

4368-56-3

Molecular formula:

C20H219N2O5S.Na

IUPAC Name:

sodium 4-(4-acetamidophenyl-1-amino)-1-amino-9,10-dioxoanthracene-2-sulphonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: TOP Velaz Ltd.
- Weight at study initiation: 150 g.
- Housing: plastic polypropylene cages T4, equipped with dry softwood chip which was sterilized in a hot air sterilizer HS 401 A/1 at 150°C for 90 minutes.
- Diet (e.g. ad libitum): standard commercially manufactured complete Mixed fodders ST-1, 10 g/animal/day.
- Water (e.g. ad libitum): drinking water according to CSN 757111 ad libitum.
- Acclimation period: one week.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C.
- Humidity: 50 ± 15%
- Photoperiod: 12 hrs cycle dark/light.
- Other: fluorescent light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% suspension

Doses:

7.943 g/kg, 8.913 g/kg, 10.00 g/kg, 12.59 g/kg

No. of animals per sex per dose:

5 per sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: the animals were observed for clinical signs of intoxication immediately after application (after 30 minutes), 3 hours after application and once a day for 14 days.
- Frequency of weighing: the animals were weighed before the oral administration and during the observation period.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical diagnosis was focused on observation of the appearance of skin, fur, visible mucous membranes, nutritional status, mental activity, somatomotor activity, responses to stimuli, focusing on sensibility and reactivity, lacrimation, assessment function respiratory, digestive, urogenital and circulatory system. Organs and muscles were examined macroscopically. After dissection internal organs were judged according to their color, size, consistency and structure. If the post-mortem bladder is filled with urine, the urine were carried out biochemical tests indicative indicator strips Heptaphan focusing on the detection of proteins, blood sugars, ketones, bilirubin, urobilinogen and pH.

Statistics:

LD50 is calculated by the probit method according to Bliss. Mortality data used and the frequency and level logarithmic doses were entered into a computer and analyzed by the program PROBIT from October 1991 VÚOS.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 9 476.1 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 7 943 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 6 633.27 mg/kg bw

Based on:

act. ingr.

Mortality:

Mortality is observed in doses higher than 7.943 g/kg.

Clinical signs:

other: After application of the logarithmic dose of 12.59 g / kg the following clinical symptoms of intoxication were observed: - appearance of skin and hair: blue coloration of the skin after application and smoot, shiny hair - nutritional status: good - appear

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (Male/Female, Rats) = 9476.1 mg/kg b.w. (6633.27 mg/kg b.w. based on the active ingredient)

Executive summary:

The substance has been tested for acute toxicity by oral route accordimg to the OECD Guideline 401. Forty Wistar rats were tested with the following dose: 7.943 g/kg, 8.913 g/kg, 10.00 g/kg, 12.59 g/kg.

After 14 days of observation period the rats showed weight loss in all the application doses. The clinical signs observed are: conjuntivitis, locomotion disorders due to ataxia, diarrhea, hypergie, hyperaesthesia and blue coloration of the skin.

 

The substance shows an LD50 for male and female rats over the period of 14 days equal to 9476.1 mg/kg b.w. (6633.27 mg/kg b.w. based on the active ingredient).