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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
29 Jun - 26 Sept 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.

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
GLP compliance:
no
Remarks:
pre-GLP study
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dialuminium chloride pentahydroxide
EC Number:
234-933-1
EC Name:
Dialuminium chloride pentahydroxide
Cas Number:
12042-91-0
Molecular formula:
Al2ClH5O5
IUPAC Name:
dialuminium chloride pentahydroxide
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
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)
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 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Moderate phagocytosis 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 wasapproximately 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).