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

Endpoint summary

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:

other: none

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.