Reaction mass of 1,5-dihydroxy-4-nitro-8-(phenylamino)anthraquinone and 1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

20241-76-3

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF strain)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxicology/Pathology, PH 2.635, CIBA-GEIGY Limited, Basle, Switzerland
- Weight at study initiation: 160 to 180 g
- Fasting period before study: overnight
- Housing: macrolon cages
- Diet: a standard diet of Nafag, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 h dark/14 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: carboxymethyl-cellulose 2 %

Details on oral exposure:

DOSAGE PREPARATION:
FAT 36080/A was suspended with carboxymethyl-cellulose 2 %. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Fasting details:
Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.

Doses:

6000, 7750, 9000 and 10000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, mortality check and autopsies

Statistics:

Not specified

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was recorded in animals treated at 6000 and 7750 mg/kg bw. However, 1 female at the dose of 9000 mg/kg bw as well as 2 males and 1 female at the dose of 10000 mg/kg bw were found dead at the 24 hour observation after dosing.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Sedation and ruffled fur became more accentuated as the dose was increased. The surviving animals recovered w

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 36080/A in rats was determined to be >10000 mg/kg bw.

Executive summary:

The acute oral LD50 of FAT 36080/A was determined in a study conducted according to the methodology that is equivalent to the OECD Guideline 401. Groups of 5 males and 5 females each, were administered the test item at the doses of 6000, 7750, 9000 and 10000 mg/kg bw. Clinical signs and mortality check were recorded during an observation period of 14 days. Autopsies were performed at the end of the observation period. No mortality was recorded in animals treated at 6000 and 7750 mg/kg bw. However 1 female at the dose of 9000 mg/kg bw as well as 2 males and 1 female at the dose of 10000 mg/kg bw were found dead at the 24 hour observation after dosing. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position, diarrhoea and ruffled fur. Sedation and ruffled fur became more accentuated as the dose was increased. The surviving animals recovered within 8 to 9 days. No substance related gross organ changes were seen. Hence based on the above findings, the acute oral LD50 in rats was determined to be >10000 mg/kg bw.