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Diss Factsheets

Administrative data

Description of key information

A study was performed to determine the acute oral median lethal dose (LD50 ) of the test material, administered as a suspension in arachis oil in the Sprague-Dawley CFY strain rat. The method used followed

that described in the OECO No. 401. Following a range-finding study, four groups, each of ten fasted animals (five males and five females), were given a single oral dose of test material preparation at dose levels of 100 to 800 mg/kg body weight. Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing. Principal signs of toxicity noted in both decedents and surviving animals were hunched posture, pilo-erection, lethargy and decreased respiratory rate. Occasional or isolated signs of increased salivation, ptosis, body tremors or occasional body tremors, red/brown staining around the eyes, snout and mouth with diuresis, diarrhoea, tonic convulsions, ataxia and coma. Signs of toxicity were first noted immediately after dosing. Surviving animals were normal two to eight days after dosing. All surviving animals showed expected gains in bodyweight over the study period. Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor of the liver, with congestion of the small intestines. Sloughing of the gastric mucosa was also noted. In conclusion, the acute oral LD 50 was found to be 283 mg/kg (males/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:
April - June 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Description: Crystalline white powder
- Name: P0071
- Storage requirements: 4°C in the refrigerator
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 126 - 148g; females 114 - 148g
- Fasting period before study: yes
- Housing: housed in groups of up to five by sex in solid-floor PP-cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 45-55%
- Air changes (per hr): 15 changes/h
- Photoperiod (hrs dark / hrs light): 12h light / 12h darkness
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500, 200, 100, 50, 25, 10 mg/ml in pretest; 10, 20, 40, 80 mg/ml in main test
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: non-reactivity and suspensability
Doses:
- Pretest: 5000, 2000, 1000, 500, 250, 100 mg/kg
- Main test: 100, 200, 400, 800 mg/kg
No. of animals per sex per dose:
- Pretest: 1 male / 1 female per dose group
- Main test: 5 males / 5 females per dose group
Control animals:
no
Details on study design:
Duration of observation period following administration:
Immediately after dosing and at 6, 12 and 18 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation

Frequency of observations and weighing:
Individual bodyweights were recorded on the day of treatment (day 0), days 7 and 14, and at death

Necropsy of survivors performed: yes
All animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained
Statistics:
as prescribed in method
Preliminary study:
- 5000, 2000, 1000, 500 mg/kg: mortaliity: 2/2 (100%)
- 250, 100 mg/kg: mortaliity: 0/0 (0%)
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
283 mg/kg bw
Based on:
test mat.
95% CL:
191 - 419
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
283 mg/kg bw
Based on:
test mat.
95% CL:
175 - 457
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
283 mg/kg bw
Based on:
test mat.
95% CL:
210 - 382
Mortality:
Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing.
Clinical signs:
other: 100 mg/kg All animals treated with 100 mg/kg showed hunched posture and piloerection immediately after dosing, six, twelve and eighteen hours after dosing and on day one. Additional signs of lethargy and decreased respiratory rate were also noted immediat
Gross pathology:
Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor or the liver and congestion of the small intestines. Sloughing of the glandular region of the stomach was also noted. No abnormalities were noted at necropsy of surviving animals killed at the end of the study period.
Other findings:
None
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The acute oral LD 50 was found to be 283 mg/kg (males/females)
Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50 ) of the test material, administered as a suspension in arachis oil in the Sprague-Dawley CFY strain rat. The method used followed

that described in the OECO No. 401. Following a range-finding study, four groups, each of ten fasted animals (five males and five females), were given a single oral dose of test material preparation at dose levels of 100 to 800 mg/kg body weight. Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing. Principal signs of toxicity noted in both decedents and surviving animals were hunched posture, pilo-erection, lethargy and decreased respiratory rate. Occasional or isolated signs of increased salivation, ptosis, body tremors or occasional body tremors, red/brown staining around the eyes, snout and mouth with diuresis, diarrhoea, tonic convulsions, ataxia and coma. Signs of toxicity were first noted immediately after dosing. Surviving animals were normal two to eight days after dosing. All surviving animals showed expected gains in bodyweight over the study period. Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor of the liver, with congestion of the small intestines. Sloughing of the gastric mucosa was also noted. In conclusion, the acute oral LD 50 was found to be 283 mg/kg (males/females).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
283 mg/kg bw
Quality of whole database:
Guideline study; Klimisch 1

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

Justification for classification or non-classification

Based on the results of this study, the test item has to be classified as "Acute toxic, Cat. 3, oral".