Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-24 to 1985-06-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: male: 91-113 g, female: 102-112 g
- Housing: up to 5 animals per dose per sex in polypropylene cages
- Diet: ad libitum, no food over night before treatment and 2 h after treatment, Rat & Mouse Expanded Diet No. 1, supplied by Special Diet Services Limited, Witham, Essex
- Water: ad libitum, tap water
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45-66
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2.5, 20, 200, 500 mg/mL
- Amount of vehicle: 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL
Doses:
25, 200, 2000, 5000 mg/kg bw
No. of animals per sex per dose:
2 for range finding test, 5 for main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed 0.5, 1, 2, 3, 4, 5 h and afterwards once per day after treatment. The bodyweight was measured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ
Statistics:
No data provided.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One male animal (5000 mg/kg bw) died between day 2 and 3.
Clinical signs:
Hunched posture and pilo erection were observed in all rats and all dose levels. Diarrhoea was observed in single rats at 25 and 200 mg/kg bw levels. Respiratory decrease (≥ 200 mg/kg bw), lethargy and increased salvivation (≥ 2000 mg/kg bw) were observed. Starting from day 2 no clinical signs were detected.
Body weight:
No toxicological related changes were observed.
Gross pathology:
Animal that died: congestion of the lungs, ulceration and haemorrhage of glanular region of the stomach and haemorrhage of intestinal tract
Animals sacrified: No macroscopic abnormalities
Other findings:
No other observations were made.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute oral toxicity study in rats was conducted. The acute oral LD50 was established to be greater than 5000 mg/kg bw.
Executive summary:

An acute oral toxicity using the standard acute method according to OECD 401 was performed with rats. 25, 200, 2000 and 5000 mg/kg bw of the test substance were administered to rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. All dose levels of the test substance produced signs of toxicity like a hunched posture and piloerection. Other signs like lethargy and increased salivation were observed for high doses only. The animals were symptom free starting from day 2 after treatment. One animal of the dose group 5000 mg/kg bw died between day 2 and 3. Due to these results the test substance was considered to be practically nontoxic and the oral LD50 > 5000 mg/kg bw was derived for rats.