Reaction mass of 2-(1,1-dimethylpropyl)anthraquinone and 2-(1,2-dimethylpropyl)anthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

- Substance type: Technical product.
- Storage condition of test material: No data.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/CPB, Zeist, The Netherlands.
- Weight at study initiation: 209-214 g males / 159-168 g females.
- Fasting period before study: 18-19 hours prior to dosing until 5.5-6 hours after dosing.
- Housing: stainless steel wire cages with two or three animals per cage.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 21-23°C.
- Humidity: 40-70%.
- Air changes: approximately 16 air changes per hour.
- Photoperiod: 12 hours light / 12 hours dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.05, 0.1 and 0.2 g/ml corn oil.
- Amount of vehicle (if gavage): 5 ml/kg.

Doses:

250, 500, 1000 and 2000 mg/kg

No. of animals per sex per dose:

five males and five females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: the rats were observed 0-0.5, 1.5, 3, 5-5.5, 24 and 48 hours after application and thereafter once daily till the end of the study. Rats were weighed one day before and at 2, 7 and 14 days after dosing.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 1 000 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Oral administration of a single dose of 2000 mg/kg killed all male and female rats within 5-48 hours after dosing. All animals dosed at lower levels survived the 14-day observation period.

Clinical signs:

other: Clinical signs at dose level 2000 mg/kg b.w.: clinical signs were slight to severe in intensity (e.g. apathy, abnormal gait and posture, decreased body tone, decreased respiratory rate, respiratory difficulties, decreased locomotor activity, positional pa

Gross pathology:

Post-mortem examination of male and female rates that died during the observation period revealed rigor, dark urine, small and maculate thymus
glands, enlarged and dark adrenals and food-filled stomachs. In the animals that survived the 14-day observation period, slightly darkened adrenals were observed in one male dosed at 1000 mg/kg. Adrenals were found to be enlarged in 2 females given 1000 mg/kg and in 1 female dosed at 250 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

other: Based on Regulation 1272/2008/EC, the substance is classified as Acute Tox. 4, H302.

Conclusions:

In a GLP-compliant guideline study, acute oral LD50 of 2-amylanthraquinone in rats was calculated to be between 1000-2000 mg/kg bw. Based on this classification of the substance as Acute Tox. 4, H302 is warranted under Regulation 1272/2008/EC.

Executive summary:

In a GLP-compliant OECD Guideline 401 study 2 -amylanthraquinone was administered by gavage in doses of 250, 500, 1000 and 2000 mg/kg bw to the groups of five males and five females. Administration of a single dose of 2000 mg/kg killed all male and female rats within 5-48 hours after dosing. All animals dosed at lower levels survived the 14-day observation period. Male rats dosed at 1000 mg/kg and females dosed at 500 or 1000 mg/kg lost some weight in the first few days after treatment.

The LD50 was calculated as 1000-2000 mg/kg bw. Based on this the substance should be classified as Acute Tox. 4, H302 (Harmful if swallowed) under Regulation 1272/2008/EC.