[carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for Testing of Chemicals no. 403, adopted 12 May, 1981.

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

422-150-1

EC Name:

-

IUPAC Name:

422-150-1

Details on test material:

Physical form of substance: S
Mass median aerodynamic diameter (for liq.+solid aerosol):
particle size cumulative %

<= 0.7 9.9

<= 1.1 30.4

<= 1.9 48.5

<= 3.1 79.5

<= 5.0 91.2

<= 8.2 100

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: none used

Details on inhalation exposure:

nose only

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.16 +/- 0.48 g/m3

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.16 mg/L air

Exp. duration:

4 h

Mortality:

Male: 5.16 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.16 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: During exposure: Slight visually decreased breathing rate in all animals. After exposure: Cold upon touching (2M/1F) directly after exposure. Dirty fur of the head (2F) until day 7. Alopecic area

Body weight:

In general slightly reduced mean body weight gain was seen seven days after exposure.

Gross pathology:

Macroscopic:

Sparsely haired abdomen (1F).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU