Reaction mass of aluminium chloride, iron dichloride, magnesium chloride and manganese dichloride

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

29 June 1972 - 26 September 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted before the introduction of GLP and not according to an OECD guideline. However, the study has a proper design and the report is concise.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)

Deviations:

yes

Remarks:

Pre-guideline study

Principles of method if other than guideline:

Not relevant

GLP compliance:

no

Remarks:

pre-GLP study

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dialuminium chloride pentahydroxide

EC Number:

234-933-1

EC Name:

Dialuminium chloride pentahydroxide

Cas Number:

12042-91-0

IUPAC Name:

dialuminium chloride pentahydroxide

Test material form:

other: aerosol

Remarks:

solid/liquid

Details on test material:

- Name of test material (as cited in study report): Aluminiumhydroxychlorid
- Substance type: Aerosol
- Physical state: Solid/Liquid
- Composition of test material, percentage of components: Confidential information

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Remarks:

(exposure room of 10 m3)

Vehicle:

other: unchanged (no vehicle)

Remarks on MMAD:

MMAD / GSD: No data

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

65 seconds (1x10 and 11x5 seconds) in 6 hours on exposure days

Frequency of treatment:

65 times in 90 days

Doses / concentrations

Remarks:

Doses / Concentrations:
9.0% Aluminiumhydroxichlorid
Basis:
nominal conc.

No. of animals per sex per dose:

10

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

Dose descriptor:

LOAEC

Effect level:

15.3 mg/m³ air (nominal)

Sex:

male/female

Basis for effect level:

other: Moderate phagocytose in the lungs and small dust spread into lymph peribronchial lymph nodes

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

The daily amount of deodorant sprayed averaged 121.6 g. In the course of 90 days, in total 7785 g of product was sprayed .The entire Locron P consumption is therefore about 700 g. The concentration of deodorant in the exposure room was approximately 170 mg/m3 in the first 10 seconds of the first exposure. It is unclear what the average exposure concentration of test substance was.

Study results

Mortality/viability: One male rat died after 62 days of inhalation without clear symptoms

No adverse effects were observed on body weight, blood and urine, as well as albumine/globuline in blood and enzymeactivities. Organ weights were also normal.

Macro and microscopic examination: All animals in the test group showed moderate phagocytose in the lungs and small

dust spread into lymph peribronchial lymph nodes.

Applicant's summary and conclusion

Conclusions:

LOAEC = 15.3 mg/m3. Some pathological effects were found: All animals in the test group showed moderate phagocytose in the lungs and small dust spread into lymph peribronchial lymph nodes at the tested concentration and under the conditions of this study.

Executive summary:

The effects of 90-day exposure of rats to deodorant spray containing 9% aluminiumhydroxychloride was tested in this inhalation study. 10 male and 10 female rats were exposed, while another 10 males and females formed the control group.

Clinical signs, body weights, blood and urine and macro and microscopic abnormalities were recorded.

One male rat died after 62 days of inhalation without clear symptoms. No adverse effects were observed on body weight, blood and urine, as well as albumine/globuline in blood and enzymeactivities. Organ weights were also normal.

Macro and microscopic examination showed moderate phagocytose in the lungs and small dust spread into lymph peribronchial lymph nodes in all animals.

A LOAEC of 15.3 mg/m3 could be established (only concentration tested).