Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 870.1000
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Animals female non-pregnant nulliparous
Full barrier in air-conditioned room Temperature 22+/- 3 C
Relative humidity 55+/- 10 %
Artificial light 12h light/ 12h dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
The test item was administered at a single dose by gavage using a feeding tube.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
Two groups, each of 3 female Wistar rats were treated with the test item by gavage at a dosage of 2000 mg/kg bw. The test item was suspended in non-toxic corn oil at dose volume of 10 ml/kg bw. The animals were observed for clinical signs several times at the day of dosing and daily until 14 days after dosing, when the animals were sacrificed. Body weights were recorded on day 1 (prior to dosing) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during both steps.
Clinical signs:
The most relevant clinical findings were apathy and piloerection (2 animals).
Body weight:
Throughout the 14-day observation period, the body weight gain of the animals was within the normal range of variation for this strain
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: EU / OECD GHS
Conclusions:
The median lethal dose of aluminium dross after a single oral administration to female rats observed over a period of 14 days was more than 2000 mg/kg bw. As a result LD50 cut off (rat): unclassified
Executive summary:

Two groups, each of 3 female Wistar rats were treated with the test item by gavage at a dosage of 2000 mg/kg bw. The test item was suspended in non-toxic corn oil at dose volume of 10 ml/kg bw. Details of housing and feeding conditions are given. The animals were observed for clinical signs several times at the day of dosing and daily until 14 days after dosing, when the animals were sacrificed. Body weights were recorded on day 1 (prior to dosing) and on days 8 and 15. All animals were necropsied and examined macroscopically. There were no deaths during both tests. The most relevant clinical findings were apathy and piloerection (2 animals). Throughout the 14 day observation period the body weight gain of the animals within the normal range of variation for this strain. At necropsy no macroscopic findings were observed in any animal of any step. On the basis of the test results aluminium dross is characterized as “not classified” for acute oral toxicity