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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.08.1982 to 03.09.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: other: Safepharm protocol (number GM 11/80/21A), broadly comparable with now deleted OECD 401 at limit dose.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Tuck & Sons Limited, Battlesbridge, Essex.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: Males: 92-110 g; Females: 103-115 g
- Fasting period before study: Yes, overnight
- Housing: Groups of five in polypropylene cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): 65-72
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 20.08.1982 to 03.09.1982

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
10 ml/kg
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: Animals were observed 0.5, 1, 2, 3, 4 and 5 hours following dosing. On subsequent days the animals were observed at least once. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
None required

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Mortality:
Two females died with 3-4 hours of dosing. No other deaths occurred.
Clinical signs:
Pilo-erection, abnormal body carriage (hunched posture), lethargy and decreased respiratory rate. These signs were accompanied by ptosis in two males and one female and pallor of the extremities in one female. Recovery of survivors occurred by Day 2.
Body weight:
Slightly depressed body weight gains were observed in two male and all surviving female rats during the first week of observation, and in one other male rat during the second week of observation.
Gross pathology:
Congestion of the lungs in both animals that died and haemorrhage of the small intestine in one. There were no abnormal findings in surviving animals.
Other findings:
None

Any other information on results incl. tables

The LD50 in the rat was determined to be >10 ml/kg (equivalent to >5740 mg active salt/kg bw).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral limit study conducted to GLP (reliabilty score 1) the LD50 for Briquest 301-32S (a sodium salt of ATMP) was greater than 10 ml/kg (calculated to be equivalent to >4436 mg parent acid/kg bw) in rats.
Executive summary:

In an acute oral limit study conducted to GLP (reliability score 1) the LD50 for Briquest 301-32S (a sodium salt of ATMP) was greater than 10 ml/kg (calculated to be equivalent to >4436 mg parent acid) in rats.