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Toxicological information

Acute Toxicity: oral

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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

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.