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EC number: 234-933-1 | CAS number: 12042-91-0
Repeated dose toxicity: inhalation
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
- 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.
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.One cat of the control group showed increased leukocyte values and gamma-globulin values, of which the last was caused by an infection.
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).
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.
Macro and microscopic examination: All animals in the test group showed moderate phagocytose in the lungs and small
- 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
- 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.
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.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.
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).
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
- 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
- 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.
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.One rabbit of the control group showed increased gamma-globulin values, which was caused by an infection.
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).
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
Macro and microscopic examination: All animals in the test group showed moderate phagocytose in the lungs and small
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- 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 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
Constituent 1
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).
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