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Description of key information

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:
From February 13, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
- Lot No.: LAB.J.-NO.: 6107/1427
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animal breeder: dr. K Thomae GMBH, Biberach
Acclimatization period: at least one week
Number of animals per dose: 5 males/ 5 females
Type of cage: stainless steel wire mesh cages, type DK-III
Bedding: no bedding in the cages, sawdust in the waste trays
No. of animals per cage: 5
Identification: using cage cards and tails marking
Room temperature/relative humidity: the animals were housed in fully air-conditioned rooms, 20 -24 °C and 30-70 % of relative humidity.
Day/night rhythm: 12/12
Drinking water: ad libitum per day
Diet: Kliba-labordiaest 343
Food and water was assayed for contaminants
Animal weights: young adult animals of comparable weight
Fasting period: the animals were given no feed about 16 hours before administration but water was available ad libitum
Route of administration:
oral: gavage
Vehicle:
other: aqua dest.
Details on oral exposure:
Route of administration: single oral administration by gavage
Test substance formulation with aqua dest.
Form of administration: suspension
Doses:
Reason for the doses: based on the chemical and physical characteristic of the test substance no pronounced acute oral toxicity was expected, therefore the following dose has been chosen for the study: 2200 mg/kg bw.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
Observations: Signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Pathology: Withdrawal of food about 16 h before sacrifice with CO2, then necropsy with gross-pathological examination.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 200 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Gross pathology:
No pathologic findings noted
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute oral LD50 of the test substance in Wistar rat was >2200 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 401, in compliance with GLP. Groups of 5 females and 5 males were dosed by gavage with the test substance suspended in aqua dest at a single limit dose of 2200 mg/kg bw. The rats were then observed for 14 d for mortality, clinical signs and bodyweight changes. Upon completion of the study, the stability of the substance was analytically verified. There was no mortality and no evident signs of toxicity or bodyweight loss were observed. The results of the chemical analysis confirmed the top dose to be 27.1 g/100 ml, 23% higher than the nominal value. Under the study conditions, the acute oral LD50 of the test substance in Wistar rat was >2200 mg/kg bw (Kirsch, 1990).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989/90
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
to form a paste
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no animal died
Clinical signs:
no effects
Body weight:
slight body weight loss in females on day 7
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

A study was conducted to determine the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 401, in compliance with GLP. Groups of 5 females and 5 males were dosed by gavage with the test substance suspended in aqua dest at a single limit dose of 2200 mg/kg bw. The rats were then observed for 14 d for mortality, clinical signs and bodyweight changes. Upon completion of the study, the stability of the substance was analytically verified. There was no mortality and no evident signs of toxicity or bodyweight loss were observed. The results of the chemical analysis confirmed the top dose to be 27.1 g/100 ml, 23% higher than the nominal value. Under the study conditions, the acute oral LD50 of the test substance in Wistar rat was >2200 mg/kg bw (Kirsch, 1990).

A study was conducted to determine the acute dermal toxicity of the test substance in Wistar rats according to OECD Guideline 402, in compliance with GLP. The test substance was applied to the intact skin of 5 female and 5 male rats at a single limit dose of 2000 mg/kg bw. The rats were then observed for 14 d for mortality, clinical signs and bodyweight changes. There was no mortality and no evident signs of toxicity or bodyweight loss were observed. Under the study conditions, the acute dermal LD50 of the test substance in Wistar rat was >2000 mg/kg bw (Kirsch, 1990).

Justification for classification or non-classification

Based on the results of acute toxicity studies in rats, the substance does not require classification for this endpoint according to CLP (EC 1272/2008) criteria.