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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
29 June 1972 - 26 September 1972
Reliability:
4 (not assignable)
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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aluminiumhydroxychlorid
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- 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:
Under the test conditions of this study, 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).