1,4-dichloro-5,8-dihydroxyanthraquinone

Endpoint summary

Description of key information

Acute oral toxicity: discriminating dose >5000 mg/kg bw; RL2; pre-GLP

Acute dermal toxicity: no study available

Acute inhalation toxicity: no study available

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Principles of method if other than guideline:

No specific Guideline stated.

GLP compliance:

no

Remarks:

Study conducted prior to implementation of GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Wistar TNO W 74

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9-14 weeks
- Weight at study initiation: 175 g (mean weight male/female)
- Housing: makrolon cages (type III)
- Diet (e.g. ad libitum): Altromin R 1324
- Water (e.g. ad libitum): tap water

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

Route of administration:

oral: gavage

Vehicle:

poloxamer

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

one single dose of 5 g/kg bw

No. of animals per sex per dose:

5 male, 5 female

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: multiple on day of application, followed by twice a day (once at weekends and bank holidays); weighing on day of application and at end of observation period
- Necropsy of survivors performed: no information
- Other examinations performed: observation of clinical signs during the observation period

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

none

Body weight:

no impact

Gross pathology:

no information

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of 5,8-Dichlorchinizarin in male and female rats was > 5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study, 5 female and 5 male, 9-14 weeks old Wistar strain rats were given a single oral dose of 5,8-Dichlorchinizarin in poloxamer (Lutrol) by gavage at a dose of 5000 mg/kg bw and observed for 14 days.

During the observation period, no death, no clinical signs and no impact on weight were observed in any animal.

Oral LD50 (rat, male/female) > 5000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure'. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

Justification for classification or non-classification

Based on the available relevant and reliable data, the test substance does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute toxicity. No studies were available for acute dermal and acute inhalation toxicity. According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure'. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.