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Administrative data

Description of key information

Acute oral toxicity (tested in a study similar to OECD TG 401): LD50 > 5000 mg/kg bw

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:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: [Crl:CD: (SD) BR]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K.
- Age at study initiation: Approximately 4 to 6 weeks
- Weight at study initiation: 113 to 147 grams
- Fasting period before study: overnight prior to and 4 hours after dosing
- Housing: Housed in groups by sex in metal rodent cages with wire mesh floors.
- Diet: standard laboratory rodent diet (Labsure LAD 1), ad libitum.
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): daily mean 67
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
1.55 and 3.87 mL/kg

Doses:
2000 and 5000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations were made soon after dosing and at frequent intervals for the remainder of day 1 (a minimum period of 5 hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week days or 11.30 on Saturday and Sunday. Clinical signs were recorded at each observation. Approximate time of death, nature, severity, approximate time of onset and duration of each toxic sign were recorded. Individual body weights were recorded on day 1, 8, 15 and at death.
- Necropsy of survivors performed: yes, surviving animals were killed on day 15 by cervical dislocation. All animals that died during the study and those killed on day 15 were subject to macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Single death occurred amongst male rats dosed at 2.0 g/kg and amongst rats of both sexes treated at the higher dose level following oral administration of the test substance. Death occured on days 2 and 5.
Clinical signs:
Pilo-erection and increased salivation were observed in all rats within five minutes of dosing. Other clinical signs, apparent within four hours of dosing were limited to rats at the higher dose level and included abnormal body weight carriage (hunched posture), abnormal gait (waddling), lethary, decreased respiratory rate, ptosis and pallor of the extremities.
Recovery of the majority of rats surviving treatment, as judged by external appearance and behaviour, was complete on day 2 (2.0 g/kg) or day 3 (5.0 g/kg)
One male dosed at 2.0 g/kg developed pilo-erection, lethargy, decreased respiratory rate, pallor of the extremities, ataxia, and body tremors on day 3, Ptosis and prostration on day 4 and was found dead on day 5.
Body weight:
Bodyweight losses (≤ 30 g) were recorded for rats that died.
All surviving rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
Autopsy of rats that died did not reveal any abnormalities.
Terminal autopsy of the surviving animals were normal.
Interpretation of results:
other: not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.
Executive summary:

Benzoin hypersoluble is tested for acute oral toxicity in a study performed similar to OECD TG 401. Three rats [Crl:CD: (SD) BR] per sex, per dose, were exposed to 2000 or 5000 mg/kg bw test substance via oral gavage. After an observation period of 14 days animals were necropsied.

In this study one animal died in the 2000 mg/kg bw dose group on day 5 and two in the 5000 mg/kg bw dose group on day 2. Pilo-erection and increased salivation were observed in all rats within five minutes of dosing. Other clinical signs, apparent within four hours of dosing were limited to rats at the higher dose level and included abnormal body weight carriage (hunched posture), abnormal gait (waddling), lethary, decreased respiratory rate, ptosis and pallor of the extremities. Recovery of the majority of rats surviving treatment, as judged by external appearance and behaviour, was complete on day 2 (2.0 g/kg) or day 3 (5.0 g/kg). One male dosed at 2.0 g/kg developed pilo-erection, lethargy, decreased respiratory rate, pallor of the extremities, ataxia, and body tremors on day 3, Ptosis and prostration on day 4 and was found dead on day 5. Bodyweight losses (≤ 30 g) were recorded for rats that died. All surviving rats achieved anticipated bodyweight gains throughout the study. Autopsy did not reveal abnormalities in any of the exposed rats. The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity:

Benzoin hypersoluble is tested for acute oral toxicity in a study performed similar to OECD TG 401. Three rats [Crl:CD: (SD) BR] per sex, per dose, were exposed to 2000 or 5000 mg/kg bw test substance via oral gavage. After an observation period of 14 days animals were necropsied.

In this study one animal died in the 2000 mg/kg bw dose group on day 5 and two in the 5000 mg/kg bw dose group on day 2. Pilo-erection and increased salivation were observed in all rats within five minutes of dosing. Other clinical signs, apparent within four hours of dosing were limited to rats at the higher dose level and included abnormal body weight carriage (hunched posture), abnormal gait (waddling), lethary, decreased respiratory rate, ptosis and pallor of the extremities. Recovery of the majority of rats surviving treatment, as judged by external appearance and behaviour, was complete on day 2 (2.0 g/kg) or day 3 (5.0 g/kg). One male dosed at 2.0 g/kg developed pilo-erection, lethargy, decreased respiratory rate, pallor of the extremities, ataxia, and body tremors on day 3, Ptosis and prostration on day 4 and was found dead on day 5. Bodyweight losses (≤ 30 g) were recorded for rats that died. All surviving rats achieved anticipated bodyweight gains throughout the study. Autopsy did not reveal abnormalities in any of the exposed rats. The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for acute oral toxicity in accordance with the criteria outlined in EU CLP (EC no 1272/2008 and its amendments).