Dialuminum tetramagnesium carbonate dodecahydroxide

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:

1997

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:

423-570-6

EC Name:

-

IUPAC Name:

423-570-6

Details on test material:

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

<= 0.7 9.6

<= 1.1 27.7

<= 1.9 43.5

<= 3.1 63.9

<= 5.0 73.7

<= 8.2 87.5

<= 20.5 98.2

<= 32 99.6

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:

5.17 +/- 0.29 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:

> 5.17 mg/L air

Exp. duration:

4 h

Mortality:

Male: 5.17 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.17 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 during the first two hours, aggravating to moderate decreased breathing rate in the last two hours. In addition slight laboured breat

Body weight:

No effect on body weight.

Gross pathology:

Effects on organs:
Findings at necropsy were limited to discouration of the
lungs seen in three animals.

Any other information on results incl. tables

Comments:
none.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU