reaction product of alumina and sulfuric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 4. Nov. 2016 to 24. Nov. 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certicate not attached

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction product of alumina and sulfuric acid

EC Number:

812-508-7

Cas Number:

1093112-19-6

Molecular formula:

unspecified, UVCB substance

IUPAC Name:

reaction product of alumina and sulfuric acid

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

6 female rats (non-pregnant and nulliparous), 8-12 weeks old, healthy
housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, average room temperature: 22.1 +/- 0.3°C, relative humidity: 56.2 +/- 2.5%, 12-hours light/12hours dark, bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
laboratory food ssniff (Spezialdiäten GmbH, Germany), unlimited supply of drinking water (tap water)
Each animal was marked with an ID number on the tail with an ink marker

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

no food over-night before dosing, no food over 3-4 hours after dosing, free access to drinking water
because the test substance seemed to be not toxic, 3 animals were dosed with the limit dose. As no related mortality was observed during 24 hours, a second group of 3 animals was dosed

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 X 3

Control animals:

other:

Details on study design:

3 animals were dosed, because no mortality occured during 24 hours, the next 3 animals were dosed too

Statistics:

not made

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (total fraction)

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

none

Clinical signs:

during the first 4 hour (very intensive observation) and the 14 day observation period, no clinincal signs were observe

Body weight:

stagnation of body weight in 4 from 6 animals

Gross pathology:

no macroscopic findings noticed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the Sulfuric acid, reaction product with alumina is higher than 2000 mg/kg bw