2,3-dihydro-1,4-dihydroxyanthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-07-08 - 1981-07-22

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:

1982

Materials and methods

Principles of method if other than guideline:

- Principle of test: comparable to guideline study OECD 420, test was performed in 1981, before OECD guideline was published.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3-dihydro-1,4-dihydroxyanthraquinone

EC Number:

254-942-4

EC Name:

2,3-dihydro-1,4-dihydroxyanthraquinone

Cas Number:

40498-13-3

Molecular formula:

C14H10O4

IUPAC Name:

2,3-dihydro-9,10-dihydroxyanthracene-1,4-dione

Details on test material:

CAS # 40498-13-3

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMA
- Source: WISW (SPF Cpb), Winkelmann, Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks (male), 14 weeks (female)
- Weight at study initiation: 169 g (mean; male), 158 g (mean; female)
- Fasting period before study: yes (16 h before and 4 h after application)
- Housing: Makrolon cages (type III), 5 rats per cage
- Diet (e.g. ad libitum): Altromin 1324 pellets
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

poloxamer

Remarks:

in report named "Lutrol"

Details on oral exposure:

application volume: 20 ml/kg bw

Doses:

5,0 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several observations at day of application followed by twice a day (once at weekends/bank holidays)
- Frequency of weighing: at application, after 1 week, after 2 weeks
- Necropsy of survivors performed: yes (spot tests)

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no

Clinical signs:

other: weight loss

Gross pathology:

No pathological anatomical findings were reported in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance in male and female rats was >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study in general comparable to OECD Guideline 420, one dose group, with 5 males and 5 females, fasted, 9 and 14 weeks old Wistar strain rats given a single oral dose of Dihydrochinizarin in Poloxamer (named Lutrol) by gavage at a dose of 5000 mg/kg bw and observed for 14 days.

No animal died during the observation period. Clinical signs reported but not quantified: weight loss

Oral LD50 (rat, males/females) > 5000  mg/kg bw