Registration Dossier

Administrative data

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.