Registration Dossier

Administrative data

Description of key information

OECD 423 (BASF SE, 2015): Acute toxicity oral: no mortalities, LD50 > 2000 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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline- and GLP-conformant study
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
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:
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
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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A Klimisch 1 Guideline- and GLP-conformant study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity was tested in an OECD testing guideline 423 study (Acute Oral toxicity - Acute Toxic Class Method). Female rats were administered 300 or 2000 mg/kg bw test substance by gavage (3 animals and 2x3 animals, respectively). In the following 14 day observation period, no mortalities occurred. No clinical signs or gross pathology findings were recorded. Therefore, the LD50 dose level was set at > 2000 mg/kg bw in rats.


Justification for selection of acute toxicity – oral endpoint
Guideline- and GLP-conformant study with robust study summary

Justification for classification or non-classification

The available data do not fulfill the criteria laid out in Regulation (EC) 1272/2008 (CLP). Therefore, a non-classification of Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- is warranted.