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Diss Factsheets

Administrative data

Description of key information

The LD50 value of the test item was determined to be 858.0 mg/kg bw in males and 602 mg/kg bw in females.

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:
September 1984 and October 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1979
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 164 - 205 g (males); 162-193 g (females)
- Fasting period before study: 16 hours before application
- Housing: in groups of 5 in macrolon cages
- Diet: ad libitum (Altromin 1324)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 5.0 mL/kg bw

DOSAGE PREPARATION: The test item was diluted in water to a concentration of 25% (w/v).
Doses:
315, 500, 560, 630, 800, 1000 and 1250 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopically examinations
Statistics:
- Probit analysis according to Lindner and Weber
- method according to Fieller or Sidak
Preliminary study:
No details on preliminary study.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
858 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
602 mg/kg bw
Based on:
test mat.
Mortality:
630 mg/kg bw: 3/5 (females)
800 mg/kg bw: 2/5 (males); 5/5 (females)
1000 mg/kg bw: 4/5 (males)
1250 mg/kg bw: 5/5 (males)
Clinical signs:
Clinical signs were observed in male and female rats. On day of application occured squatting position, draftee flanks, tumbling gait, calm behaviour, pilorection. One day after application prone position, trembling, tonic cramping, jumping cramps, blood coloured lacrimation, blood stained snouts and increased breathing frequency were observed. One male had temporarily light brown-coloured decay.
Body weight:
No changes were observed.
Gross pathology:
The decendents animals showed the following findings: hemorrhages in the stomach, stomach content was darkly coloured (brown), small intestine filled with yellow or reddish brown thin fluid mass, lungs filled with blood, lung was bright red, spleen was lightened, spleen was strongly diminished, pancreas was dark red and both kidneys were lightened. In one high dose male animal, liver was strongly diminished. The stomach of this animal was deformed, the urinary bladder bulging, both adrenal glands darkened, and the epididymis reddish. Animals killed at the end of the observation period were free of macroscopically visible changes.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 value of the test item was determined to be 858.0 mg/kg bw in males and 602 mg/kg bw in females.
Executive summary:

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five animals each were exposed to the test item by oral gavage at doses ranging from 315 ranging from 1250 mg/kg bw. Animals were observed for 14 days. Mortality occured in 3 of 5 females at 630 mg/kg bw, in 2 of 5 males and 5 of 5 females at 800 mg/kg bw, 4 of 5 males at 1000 mg/kg bw and 5 of 5 males at 1250 mg/kg bw. Clinical were observed in both male and female animals on day of application and one day after application. The body weight was not affected. The decendents animals showed the following macrosopic findings. Animals killed at the end of the observation period were free of macroscopically visible changes. Based on the available data, the LD50 value of the test item was determined to be 858.0 mg/kg bw in males and 602 mg/kg bw in females.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
602 mg/kg bw
Quality of whole database:
GLP and Guideline conform study.

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

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five animals each were exposed to the test item by oral gavage at doses ranging from 315 ranging from 1250 mg/kg bw. Animals were observed for 14 days. Mortality occured in 3 of 5 females at 630 mg/kg bw, in 2 of 5 males and 5 of 5 females at 800 mg/kg bw, 4 of 5 males at 1000 mg/kg bw and 5 of 5 males at 1250 mg/kg bw. Clinical were observed in both male and female animals on day of application and one day after application. The body weight was not affected. The decendents animals showed the following macrosopic findings. Animals killed at the end of the observation period were free of macroscopically visible changes. Based on the available data, the LD50 value of the test item was determined to be 858.0 mg/kg bw in males and 602 mg/kg bw in females.

Justification for classification or non-classification

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

Based on the available experimental data, the test item is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.