Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
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

Constituent 1
Chemical structure
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:
none
Body weight:
Body weights increaded in the normal range except for one animal in 300 mg/kg bw dose level group, which stopped to gain weight in the second week after administration. This finding is not regarded as substance-related effect.
Gross pathology:
no findings

Applicant's summary and conclusion