Aluminum, [(2E)-2-butenedioato(2-)-.kappa.O1]hydroxy-

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:

other: Guideline- and GLP-conformant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]

EC Number:

810-213-8

Cas Number:

1370461-06-5

Molecular formula:

C4 H3 Al O5

IUPAC Name:

sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]

Details on test material:

- Name of test material (as cited in study report): Aluminium, [(2E)-2-butenedioato(2-)-O1]hydroxy-
- Physical state: solid / white
- Analytical purity:85.8 g/100 g (Determined by 1H-NMR-spectroscopy)
- Batch No.: 13-0001-2
- Expiration date of the lot/batch: September 30, 2016
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 166-186 g
- Fasting period before study: withdrawal of feed for at least 16 hours prior to substance administration, but water was available ad libitum
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% solution in deionized water

Doses:

300, 2000 mg/kg bw

No. of animals per sex per dose:

3 animals in 300 mg/kg bw dose group, 2 x 3 animals in 2000 mg/kg bw dose group

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Male animals are not considered to be affected more strongly than females.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no findings