Aluminium triisopropanolate

Endpoint summary

Description of key information

acute oral toxicity: LD50 ca. 11300 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Accepted well documented publication

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

In this range-finding toxicity study in Carworth-Wistar rats (Smyth et al., 1969), a single dose was administered to groups of 5 non-fasted male rats by gastric intubation. Dosages were arranged in a logarhythmic series differing by a factor of 2.

Principles of method if other than guideline:

No information on acclimation period of animals and environmental conditions

GLP compliance:

no

Remarks:

the study was conducted prior GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Garworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: no
- Diet (e.g. ad libitum): no data; Rockland rat diet, complete

Route of administration:

other: gastric intubation

Vehicle:

not specified

Details on oral exposure:

VEHICLE
suspended in 0.25% agar

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

single dose

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data

Statistics:

Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures' in parentheses show limits of ± 1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality.

Sex:

male

Dose descriptor:

LD50

Effect level:

11 300 mg/kg bw

95% CL:

> 7 000 - < 18 300

Mortality:

No data

Clinical signs:

other: No data

Gross pathology:

No data

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

11 300 mg/kg bw