Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

November 18th, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone

EC Number:

943-670-8

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone

Test material form:

liquid

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 minimumENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1- Humidity (%): 55 ± 5- Photoperiod (hrs dark / hrs light): 14 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 %OTHERNo higher doses than those administered were possible

Doses:

6000, 7750 and 10000 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities up to the highest dose.

Clinical signs:

Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. The animals recovered within 8 to 9 days. They were submitted to a necropsy at the end of the observation period.

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 > 10000 mg/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 6000, 7750 and 10000 mg/kg bw and observed for 14 days.

Within 2 hours of treatment, the rats in all the dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 9 days. They were submitted to a necropsy at the end of the observation period. The LD50 of the test substance was determined to be > 10000 mg/kg bw.

The test substance is not classified as acutely toxic by oral exposure route.