Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9-30 June 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
paste
Details on test material:
Batch: S16941
Brown paste

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K Limited, Margate, Kent , England
- Age at study initiation: approximately 6 weeks of age
- Weight at study initiation: from: 113 to 147g
- Fasting period before study: overnight period to 4 hours after dosing
- Housing: in groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet (Labsure LAD 1) ad libitum
- Water ad libitum:
- Acclimation period:8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): from 21 to 24°C
- Humidity (%): mean daily relative humidity 57%
- Air changes (per hr): 15 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.87 mL/ Kg
Doses:
2.0 g/kg and 5.0 g/kg
No. of animals per sex per dose:
3 animales per dose ans per sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 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 hours on Saturday and Sunday. Clinical signs were recorded at each observation. Bodyweights were recorded on dau 1, 8 and 15.
- Necropsy of survivors performed: yes: All animals were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities.

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Mortality:
Single deaths occured amongst male rats doses at 2.0 g/kg and amongst rats of both sexes treated at the higher dose level following oral administration of Benzoin hypersoluble. Deaths 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 carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis and palior 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 rat dosed at 2.0 g/kg developed pilo erection lethargy, decreased respiratory rate, pallor of the extremities, ataxia and boyd tremors on Day 3, ptosis and prostration on Day 4 and was found dead on Day 5.
Body weight:
bodyweight losses (< 30g) were reccorded for rats that died.
All surviving rats achivied anticipated bodyweight gains throughout the study.
Gross pathology:
No macroscopic abnormalities

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute median lethal oral dose (LD50) to rats of Benzoin Hypersoluble was found to be approximately 5 000 mg/kg bw. Therefore the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Executive summary:

In an acute oral toxicity study 3 male rats and 3 female rats were given single oral doses of Benzoin Hypersoluble at 2 and 5 g/kg bw. Animals were observed for mortality and clinical signs for 14 days.

One male doses at 2.0 g/kg was found dead at day 5 and, one male and one female doses at 5.0 g/kg were found dead at day 2.

The acute median lethal oral dose (LD50) to rats of Benzoin Hypersoluble was found to be approximately 5 000 mg/kg bw

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.