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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Method: standard method
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 'Anthrazen reinst'
Product No. 110 147

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Schering AG, Berlin
- Age at study initiation:
- Weight at study initiation: 105 - 115 (m); 90 - 100 (f)
- Fasting period before study: 16 h
- Housing: conventional, air-conditioned
- Diet (e.g. ad libitum):
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 % anthracene
- Concentration CMC: 0.5 % in water
- Amount of vehicle (if gavage): 60 %
- Justification for choice of vehicle: achieving fine distribution in an aqueous medium


MAXIMUM DOSE VOLUME APPLIED: approx. 40 mL/kg bw (calculated from data)




Doses:
16 g/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Mortality:
none
Clinical signs:
rough fur, paleness of extrimities, and hunched posture
Body weight:
normal within 14 d
Gross pathology:
low- to moderate-grade hyperemia of the lungs and moderate-grade hyperemia of the livers

Applicant's summary and conclusion