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Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 June 1972 - 26 September 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
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 for cross-reference:
reference to same study
Reference
Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting 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.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
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
Species:
cat
Strain:
not specified
Sex:
male/female
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
Remarks:
Doses / Concentrations:
9.0% Aluminiumhydroxichlorid
Basis:
nominal conc.
No. of animals per sex per dose:
Test group: 4 males
Control group: 3 males, 1 female
Control animals:
yes, concurrent no treatment
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
Critical effects observed:
not specified

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: No abnormalities

One cat of the control group showed increased leukocyte values and gamma-globulin values, of which the last was caused by an infection.

No other adverse effects were observed on body weight, blood and urine, as well as albumine/globuline in blood and enzyme activities. 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.
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 cats to deodorant spray containing 9% aluminiumhydroxychloride was tested in this inhalation study. 4 male cats were exposed, while 3 males and 1 female formed the control group.

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

No abnormalities in viability and mortality were observed.

One cat of the control group showed increased leukocyte values and gamma-globulin values, of which the last was caused by an infection.

No other adverse effects were observed on body weight, blood and urine, as well as albumine/globuline in blood and enzyme activities. 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.

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

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting 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.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
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
Species:
guinea pig
Strain:
other: Albino
Sex:
male/female
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
Remarks:
Doses / Concentrations:
9.0% Aluminiumhydroxichlorid
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
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
Critical effects observed:
not specified

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 female guinea pig died after 60 days of inhalation without clear symptoms. One male guinea pig of the control group died on day 16 on pneumonia.

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.
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 guinea pigs to deodorant spray containing 9% aluminiumhydroxychloride was tested in this inhalation study. 5 male and 5 female rats were exposed, while another 5 males and 5 females formed the control group.

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

One female guinea pig died after 60 days of inhalation without clear symptoms. One male guinea pig of the control group died on day 16 on pneumonia.

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).

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting 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.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
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
Species:
rabbit
Strain:
other: Yellow-silver
Sex:
male/female
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
Dose / conc.:
15.3 mg/m³ air (nominal)
Remarks:
Doses / Concentrations:
9.0% Aluminiumhydroxichlorid
Basis:
nominal conc.
No. of animals per sex per dose:
3
Control animals:
yes, concurrent no treatment
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
Critical effects observed:
not specified

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: No abnormalities

The body weight of the female rabbits in the control group decreased in the second half of the study.

One rabbit of the control group showed increased gamma-globulin values, caused by an infection. No other

adverse effects were observed on body weight, blood and urine, as well as albumine/globuline in blood and enzyme activities. 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.
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 rabbits to deodorant spray containing 9% aluminiumhydroxychloride was tested in this inhalation study. 3 male and 3 female rats were exposed, while another 3 males and 3 females formed the control group.

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

No abnormalities in viability/mortality were observed. The body weight of the female rabbits in the control group decreased in the second half of the study.

One rabbit of the control group showed increased gamma-globulin values, which was caused by an infection.

No other adverse effects were observed on body weight, blood and urine, as well as albumine in blood and enzyme activities. 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.

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

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

Constituent 1
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
Dose / conc.:
15.3 mg/m³ air (nominal)
Remarks:
Doses / Concentrations:
Deodorant spray, 9.0% Aluminiumhydroxichlorid
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes, concurrent no treatment

Results and discussion

Results of examinations

Mortality:
mortality observed, non-treatment-related
Description (incidence):
One male rat died after 62 days of inhalation without clear symptoms
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No adverse effects were observed on body weight
Haematological findings:
no effects observed
Description (incidence and severity):
No adverse effects were observed on blood as well as albumine/globuline in blood and enzyme activities
Urinalysis findings:
no effects observed
Description (incidence and severity):
No adverse effects were observed urine
Description (incidence and severity):
Organ weights were normal.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
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.

Effect levels

Dose descriptor:
LOAEC
Effect level:
15.3 mg/m³ air (nominal)
Based on:
other: Deodorant spray, 9.0% Aluminiumhydroxichlorid
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.

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).