Aluminum chloride, basic, reaction products with silica

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

In accordance with Annex XI, Section 1 of REACH, additional animal testing for this endpoint is not scientifically necessary as sufficient information can be gained from existing studies. Repeat dose studies are available with a maximum dose higher than would be now tested in standard OECD guideline acute toxicity protocols (OECD 423 requires an upper limit of 2000mg/kg/bw exiting studies NOAEL 4000mg/kg/bw ). Since no systemic toxicity was observed at these doses (NOAEL = top dose tested), there is no scientifice justification for conducting additional animal testing at a lower test dose.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD guideline 407 (repeated dose 28 day oral toxicity in rodents)

Deviations:

yes

Remarks:

deviation from acute protocols: rats not fasted prior to administraion;dietary study

GLP compliance:

no

Remarks:

study preceded GLP

Test type:

other: repeated dose study at a higher dosage than standard for acute toxicity protocols

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

oxo[(oxoalumanyl)oxy]alumane

EC Number:

614-074-2

Cas Number:

675106-31-7

Molecular formula:

UVCB

IUPAC Name:

oxo[(oxoalumanyl)oxy]alumane

Details on test material:

Saffil alumina fibre, Median diameters circa 3 microns and length circa 50 microns. Material is indefinitely stable at room temperature.

Test animals

Species:

rat

Strain:

other: Alpk/AP (wistar derived)

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Details on oral exposure:

6 weeks continuous exposure

Doses:

2.5% and 10% in diet (equivalent to approx)

No. of animals per sex per dose:

3 animals per sex per dose in test group

Control animals:

yes

Details on study design:

designed as a palatability /range finder for chronic dietary study

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality or clinical signs observed at top dose of 10% in diet; equivalent to over 4000mg/kg/day

Mortality:

no mortality observed

Clinical signs:

other: no effects observed

Gross pathology:

not examined

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Administration of the test substance in diet at the highest level that could be incorporated corresponded to a daily intake in excess of 6000mg/kg/day
It was concluded that the LD50 for the fibres was not less than that for calcined alumina and in excess of 4000mg/kg/day.