Aluminium triethanolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium triethanolate

EC Number:

209-105-8

EC Name:

Aluminium triethanolate

Cas Number:

555-75-9

Molecular formula:

C2H6O.1/3Al

IUPAC Name:

aluminum triethanolate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable) : NA
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 157 to 175 g
- Fasting period before study: Yes overnight before dosing and for 4 hours after.
- Housing: The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food hoppers, water bottles and bedding were changed at appropriate intervals.
- Historical data: Available on commonly used species for varying endpoints
- Diet (e.g. ad libitum): Ad libitum (except for during fasting)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Substance is hygroscopic so non-aqueous vehicle used. Corn oil is a standard vehicle in rodent toxicology studies.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No other data available so starting dose selected as 300 mg/kg as per the OECD guideline.

Doses:

300 or 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg: 1 female
2000 mg/kg: 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The weight of each rat was recorded on Days -1 (not reported), 1 (prior to dosing), 8 and 15. Individual weekly body weight changes and group mean body weights were calculated.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity, where appropriate, of any clinical signs and the time were recorded at each observation. Cages were checked twice daily for evidence of mortality.

All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of the brain, cecum, duodenum, heart, kidneys, small and large intestine, liver, lungs and bronchi, spleen, stomach, subcutaneous tissue and urinary bladder was recorded.

Statistics:

Not conducted (not a requirement of the study guideline)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during study

Clinical signs:

There were no clinical signs of reaction to treatment throughout the study.

Body weight:

A low body weight gain was seen in animal 122, dosed at 2000 mg/kg, on Days 8-15. All other animals were considered to have achieved satisfactory body weight gains throughout the study.

Gross pathology:

Pallor of the liver was seen in animal 126, dosed at 2000 mg/kg. All other animals were considered to have no abnormalities noted at the macroscopic examination at study termination on Day 15.

Other findings:

Not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be greater than 2000 mg/kg body weight.