Anthraquinone

Endpoint summary

Description of key information

Key study: Acute oral: Experimental results: EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method). GLP study. LD50 > 2000 mg/kg bw
Key study: Acute dermal: Experimental results. 
LD50 > 3000 mg/kg bw
Acute inhalation: Data waiving: In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23.6.-8.7.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was carried out in accordance with internationally valid GLP principles.

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Age at study initiation: 8-10 weeks at the time application
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage
- Diet: ST 1 BERGMAN – standard pelleted diet ad libitum
- Fasting period before study: about 20 hours
- Water: drinking tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 +/- 3°C, permanently monitored
- Humidity (%): relative humidity 30 – 70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light period 12-hour light/12 hour dark

STUDY TIME SCHEDULE
Animal supply: 18. 6. 2009
Experimental part of study: 23. 6. - 8. 7. 2009

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
Batch No.: L803142
Expiration.: 09/2009

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

DOSAGE PREPARATION: Immediately before application the test substance was weighed, mixed in vehicle (olive oil). The single volume of administered suspension was 1ml/100 g of animal body weight.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Test procedure with a starting dose of 2000 mg/kg was selected. Testing schedule (according to EU Method B.1 tris Annex 1D) START: 2000 mg/kg – 3 females (Step No.1): no deaths ► 2000 mg/kg – 3 females (Step No. 2): no deaths ► END of study

Doses:

2000 mg/kg of animal body weight

No. of animals per sex per dose:

6 animals (Step No.1 - 3 females, Step No. 2 - 3 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Time schedule of observation:
Body weight: before application, on the 8th day of study and at day 15, before euthanasia of animals
Mortality: daily
Clinical examination: daily
Pathological examination: 15th day
- Necropsy of survivors performed: yes (gross necropsy)

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

The test substance administered at the dose of 2000 mg/kg caused no death of animals.

Clinical signs:

other: No clinical signs of intoxication were detected after application in all animals.

Gross pathology:

The test substance caused no pathological changes in all animals from both groups.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study.
The test substance administered at the dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were observed in all animals. No pathologic macroscopic changes were diagnosed during pathological examination in all animals.

Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance, Anthraquinone, after a single oral administration to Wistar rats.

The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test substance was administered in a single dose as solution in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats.

The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the starting dose of 2000 mg/kg of body weight and group No.2 - second step using the same dose.

The test substance administered at the dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were observed in all animals.

No pathologic macroscopic changes were diagnosed during pathological examination in all animals

According to the study results the value of LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.

The classification of the test substance toxicity was performed according to the Directive 67/548/EEC, Annex VI. part 3.1.5. and 3.2.

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substance Anthraquinone did not fall into any of quoted categories of toxicity and has no obligatory labelling requirement in this respect.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974-1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only brief summary available

Qualifier:

no guideline available

Principles of method if other than guideline:

14 days study

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Species:

rabbit

Strain:

other: New Zealand

Sex:

female

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Applied in the form of an aqueous slurry - the test material could not be completely removed from the skin with tap water or other innocuous solvents.

Doses:

300, 1000, 3000 mg/kg

No. of animals per sex per dose:

1

Control animals:

not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

not specified

Mortality:

no

Clinical signs:

other: No pharmacotoxic symptoms were noted

Gross pathology:

Necropsy examination did not reveal any gross pathologic alterations.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 > 3000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

3 000 mg/kg bw

Quality of whole database:

Klimisch 2.

Additional information

Key study: Acute oral: Experimental results: EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method). GLP study.

LD50 > 2000 mg/kg bw

Key study: Acute dermal: Experimental results.

LD50 > 3000 mg/kg bw

Acute inhalation: Data waiving: In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity:

LD50 oral > 2000 mg/kg bw

LD50 dermal > 3000 mg/kg bw