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Diss Factsheets

Administrative data

Description of key information

In an acute oral toxicicty study an oral LD50 of 6746 mg/kg bw was determined (UN GHS: no classification) (reference 7.2.1-1).

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:
10 March 1980 - 28 July 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987 / At the time the study was performed no guideline for acute oral toxicity was established.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: ChR-CD
Sex:
male
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 33, 42, 44 and 49%
- Amount of vehicle: 4.13, 4.13, 4.47 and 4.22 mL
Doses:
6000, 7000, 7500 and 8000 mg/kg bw
No. of animals per sex per dose:
10 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 746 mg/kg bw
Based on:
test mat.
Mortality:
8000 mg/kg bw: 10/10; All deaths occurred within 3 days after dosing.
7500 mg/kg bw: 7/10; All deaths occurred within 5 days after dosing.
7000 mg/kg bw: 6/10; All deaths occurred within 3 days after dosing.
6000 mg/kg bw: 2/10; Both deaths occurred within 4 days after dosing.
Clinical signs:
other: 8000 mg/kg bw: Belly-to-cage posture, lacrimation, chromodacryorrhea, ataxia, eyes half-closed, salivation, piloerectlon, weakness, lethargy and slight weight loss after dosing. 7500 mg/kg bw: Belly-to-cage posture, lacrimation, chromodacryorrhea, eyes ha
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 was determined to be 6746 mg/kg bw.
Executive summary:

An oral LD50 test in rats was performed to determine the acut oral toxicity of the test item. A range-finding study using 1 rat/dose level was conducted to determine the initial dose level for the LD50 test. The LD50 test was performed with four dose groups (6000, 7000, 7500 and 8000 mg/kg bw) of ten young adult ChR-CD male rats. The test material, at an aqueous solution, was administered by intragastric intubation. Animals were weighed and observed during a 14-day recovery period and then sacrificed. The LD50 value was calculated from the mortality data using the method of D. J. Finney. The test item had a low toxicity when administered orally to young adult ChR-CD male rats in single doses. Clinical signs observed included belly-to-cage posture, lacrimation, chromodacryorrhea, eyes half-closed, salivation, weakness, lethargy and slight-moderate weight loss. Two animals died in the 6000 mg/kg bw dose group, six in the 7000 mg/kg bw dose group and seven animals were found dead in the 7500 mg/kg bw dose group. All animals of the 8000 mg/kg bw dose group died. All deaths occurred within 5 days after dosing. The oral LD50 was determined to be 6746 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
6 746 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

An oral LD50 test in rats was performed to determine the acute oral toxicity of the test item. A range-finding study using 1 rat/dose level was conducted to determine the initial dose level for the LD50 test. The LD50 test was performed with four dose groups (6000, 7000, 7500 and 8000 mg/kg bw) of ten young adult ChR-CD male rats. The test material, at an aqueous solution, was administered by intragastric intubation. Animals were weighed and observed during a 14-day recovery period and then sacrificed. The LD50 value was calculated from the mortality data using the method of D. J. Finney. The test item had a low toxicity when administered orally to young adult ChR-CD male rats in single doses. Clinical signs observed included belly-to-cage posture, lacrimation, chromodacryorrhea, eyes half-closed, salivation, weakness, lethargy and slight-moderate weight loss. Two animals died in the 6000 mg/kg bw dose group, six in the 7000 mg/kg bw dose group and seven animals were found dead in the 7500 mg/kg bw dose group. All animals of the 8000 mg/kg bw dose group died. All deaths occurred within 5 days after dosing. The oral LD50 was determined to be 6746 mg/kg bw.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.