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Description of key information

The median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.

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:
July/August 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WINKELMANN, Borchen
- Age at study initiation: males 9 weeks, females: 14 weeks
- Weight at study initiation: Mean weight - Males; 175-214 g, Females; 161-183 g
- Fasting period before study: from about 16 hours before till 4 hours after application
- Housing: in fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (± 1.5°C)
- Humidity (%): 60 (± 5 %)
- Photoperiod (hrs dark / hrs light): 12 hours daily
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 30 ml/kg body weight

The test substance was dissolved in water at room temperature and administered once to 5 male and 5 female animals each per dose at a constant application volume of 30 ml/kg body weight. A rigid metal gavage was used for that purpose.

The animals were inspected several times on the day of administration and twice daily during the following 14-day observation period (once on weekends and bank holidays). During
inspections the type, onset, duration and intensity of clinical signs were recorded and dead animals removed, if necessary.
Intercurrently deceased animals and those terminated at the end of study were necropsied on a random basis.
The surviving animals were individually weighed during application, after one week and at the end of the 14-day observation period.
Doses:
5000, 3100 mg/kg body weight
No. of animals per sex per dose:
5 males
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One female animal died within the first 8 hours p.a.
Clinical signs:
5000 mg/kg bw: iimpairment of general physical condition, diarrhea, nausea and sedation. The signs occurred about 1 minute after application, were of slight-to-moderate intensity and persisted until the 2nd day of study.
Body weight:
no effects
Gross pathology:
The animals killed at the end of the observation period showed slight reddening of the gastric mucosa in 2 females of the dose 5000 mg/kg bw.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.
Executive summary:

Acute oral toxicity testing in male and female Wistar rats yielded a median lethal dose (LD50) above 5000 mg/kg body weight in both male and female animals. No lethality occurred after application of 5000 mg/kg body weight. Development of body weight was not impaired. The following signs of intoxication were observed after administration of 5000 mg/kg body weight: impairment of general physical condition, diarrhea, nausea and sedation. The dose 3100 mg/kg body weight was tolerated without adverse effects. The animals killed at the end of the observation period showed no macroscopically visible changes. Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
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

Acute oral toxicity testing in male and female Wistar rats yielded a median lethal dose (LD50) above 5000 mg/kg body weight in both male and female animals. No lethality occurred after application of 5000 mg/kg body weight. Development of body weight was not impaired. The following signs of intoxication were observed after administration of 5000 mg/kg body weight: impairment of general physical condition, diarrhea, nausea and sedation. The dose 3100 mg/kg body weight was tolerated without adverse effects. The animals killed at the end of the observation period showed no macroscopically visible changes. Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.

Justification for classification or non-classification

The test substance is not classified for acute toxicity by oral exposure.