1-amino-4-hydroxy-2-phenoxyanthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 13th, 1978

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:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 060

IUPAC Name:

Disperse Red 060

Test material form:

not specified

Test animals

Species:

rat

Strain:

other: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 160 - 180 g
- Fasting period before study: overnight
- Housing: 5 animals per Macrolon cage (type 3)
- Diet: Rat food - NAFAG, Gossau SG, ad libitum
- Water: water ad libitum
- Acclimatization period: 4 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2 %

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 %
- Other: The test substance was suspended in the vehicle. Before treatment, the suspension was homogenously dispersed with an Ultra-Turrax and during treatment, it was kept stable with a magnetic stirrer.

OTHER
No higher doses than those administered were possible

Doses:

3170, 4640, 6000 and 7750 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1 hour, 24 hours, 48 hours, day 7 and day 14. The physical condition and rate of deaths of animals was monitored throughout the whole observation period
- Necropsy of survivors performed: yes. They were subjected to a necropsy whenever they died. Survivors were subjected to necropsy at the end of the observation period

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 7 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 772 mg/kg bw

Based on:

act. ingr.

Mortality:

These were the mortalities which occurred during the study:
- in the 6000 mg/kg bw group, 1 female mortality occurred after 7 d, and
- in the 7750 mg/kg bw group, 3 male mortalities and 1 female mortality occurred after 24 h.

Clinical signs:

other: Within 2 hours of treatment, the rats in the dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Surviving animals recovered within 8 to 11 d.

Gross pathology:

No substance-related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 = ca. 7000 mg/kg bw, equivalent to 2772 mg active ingredient/kg bw.

Executive summary:

The potential of the substance for acute toxicity following oral administration was tested in male and female rats of the RAIf (SPF) strain. 5 animals per sex per dose were tested at doses of 3170, 4640, 6000 and 7750 mg/kg bw and observed for 14 days.

Within 2 hours of treatment, the rats in the dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Surviving animals recovered within 8 to 11 days. They were subjected to a necropsy whenever they died. Survivors were subjected to necropsy at the end of the observation period. In the 6000 mg/kg bw group, 1 female mortality occurred after 7 d, and in the 7750 mg/kg bw group, 3 male mortalities and 1 female mortality occurred after 24 h. The LD50 of the test substance was determined to be approximately 7000 mg/kg bw.

Based on the active ingredient content, namely 2772 mg/kg bw, the test substance is not classified as acutely toxic by oral exposure route.