Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
: lack of details on test substance, no data available about the control group, no details available on the preparation of dosing solution and physical form of the administered compound.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Fumed alumina
Fumed alumina
Details on test material:
- Name of test material (as cited in study report): ALON: fumed alumina
- Physical state: Fine, fluffy, white material
- Analytical purity: “Assumed to be 100% active ingredient” (no other information available).

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River (no further information)
- Age at study initiation: No data available.
- Weight at study initiation: 183-299 grams (males) and 158-204 grams (females).
- Fasting period before study: Animals were fasted overnight prior to treatment.

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
No details available.
1000, 1590, 2510, 3980, 6310, 10000, and 15900 mg/kg bw
No. of animals per sex per dose:
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days.
Frequency of observation in all animals: immediately after dosing, 1, 4 and 24 hours after dosing, and one daily during the total of 14 days observation period.
At the end of study, gross necroscopy was performed on all animals (animals which died during the study and on those sacrificed by chloroform overdose).

No data available.

Results and discussion

Preliminary study:
Not performed.
Effect levels
Dose descriptor:
Effect level:
> 15 900 mg/kg bw
Based on:
test mat.
The fumed alumina did not cause mortality in males and females Sprague-Dawley rats after an acute oral exposure (gavage) to 1000, 1590, 2510, 3980, 6310, 10000 and 15900 mg/kg bw.
Clinical signs:
No toxic effects were noted in aluminium treated animals at doses from 1000 mg/kg to 10000 mg/kg.

At dose 15900 mg/kg, clinical signs of depression, laboured respiration, and piloerection (males) were noted immediately after administration of the compound and hunched appearance was noted at 24 hours post-administration. Animals appeared normal by day 7 (females) and day 8 (males).
Body weight:
No data available.
Gross pathology:
No changes in gross pathology were noted at sacrifice.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute oral toxicity, no classification is required.
Executive summary:

An acute oral toxicity study comparable to OECD 401 was performed with fumed alumina in female and male rats. This study has been performed at the Hazelton Laboratories, Inc.. Fumed alumina was administered by a single oral gavage to seven groups of five males and five females per group at dose levels of 1000, 1590, 2510, 3980, 6310, 10000 and 15900 mg/kg bw after an overnight food withdrawal.

Parameters monitored during this study included mortality and clinical signs of possible intoxication.Clinical observations were performed on all animals immediately after dosing, at 1, 4 and 24 hours after dosing and daily for 14 days thereafter.

During the 14 days of the observation period, there was no mortality or clinical signs of intoxication related to aluminium oxide administration at dose range from 1000 mg/kg to 10000 mg/kg bw. 

Clinical signs of depression, laboured respiration, and piloerection (males) were noted immediately and hunched appearance was noted at 24 hours post-administration of the highest dose 15900 mg/kg. 

No significant sex differences were noted among animals in the sensitivity to the administered compound or during the recovery period. Animals appeared normal by day 7 (females) and day 8 (males).

Macroscopic examination at the end of the observation period did not reveal any aluminium-related changes of the internal organs of the aluminium treated animals compared to the control group.

Under the conditions of this study, the acute oral median lethal dose (LD50) of the fumed alumina is above 15900 mg/kg bw in both females and males rats.