Aluminium lanthanum trioxide

Endpoint summary

Description of key information

Key studies and weight of evidence demonstrate a lack of potential for acute oral toxicity: Data are read-across based on grouping of substances, i.e. aluminium oxide, lanthanum oxide and aluminium lanthanum trioxide, based on inertness and similar solubility or lack thereof. Aluminium oxide and lanthanum trioxide are not acutely toxic via the oral route. Based on read-across (see category approach), it is assumed that aluminium lanthanum trioxide does not possess a potential for acute oral toxicity.

ATE aluminium lanthanum trioxide = 3652 mg/kg bw (i.e. above the classification cut-off of 2000 mg/kg bw)

Further, key studies with aluminium lanthanum trioxide demonstrate a lack of irritation/corrosion potential indicating also a low potential for local effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987-02-24

Deviations:

yes

Remarks:

purity/stability of test item missing; housing conditions of animals not described; tabulation of response data missing; body weight and gross pathological findings missing

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

not specified

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight: 200 - 300 g
- Fasting period before study: yes

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

DOSAGE PREPARATION:
50 % w/w solution in distilled water

Doses:

5.0 g/kg

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: clinical signs

Statistics:

not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 263.4 mg/kg bw

Based on:

element

Remarks:

lanthanum

Remarks on result:

other: Effect based on lanthanum content (85.3%)

Mortality:

not specified

Clinical signs:

other: not specified

Gross pathology:

not specified

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male and female rats) > 5000 mg La2O3/kg bw (> 4263 mg La/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the lanthanum trioxide is not acutely toxic via the oral route.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

not specified

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

purity/stability of test item missing; number of male and female rats not stated; number of dose levels not clearly stated; body weight measurements and pathological findings missing; LD50 determination after 10 days of observation

GLP compliance:

not specified

Test type:

standard acute method

Specific details on test material used for the study:

not specified

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age: adult
- Weight: 200 to 300 g
- Diet (ad libitum): purina® chow
- Water (ad libitum)

ENVIRONMENTAL CONDITIONS - air-conditioned room

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

DOSAGE PREPARATION
50 % aqueous suspensions of the salt was prepared and were given in a single dose by gavage.

Doses:

at least one dose level of >10000 mg/kg was given (element lanthanum only: >3500 mg/kg)(not clearly stated how many dose levels were used in the study)

No. of animals per sex per dose:

20 rats (assumed total number of rats; number of males and females were not stated and overall it is not clearly stated how many rats participitated in the study)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: all animals were observed for 10 d, but initial groups receiving a given compound were kept for 30 d to ascertain if any significant mortality occurred after day 10. However, the 10-d observation period was sufficient.

Statistics:

The LD50 values were obtained from ten day mortality data by using the log-probability method. No sex differences were noted and the LD50 value was therefore derived from the combined data on both sexes.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 500 mg/kg bw

Based on:

element

Remarks:

lanthanum

Remarks on result:

other: Effect based on lanthanum content (~ 35%)

Mortality:

All animals survived.

Clinical signs:

other: not specified

Gross pathology:

not specified

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rats; combined sexes): >10000 mg La2O3/kg bw (>3500 mg La/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, lanthanum trioxide is not acutely toxic via the oral route.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

not specified

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

purity/stability of test item missing; number of male and female rats not stated; number of dose levels not clearly stated; body weight measurements and pathological findings missing; LD50 determination after 10 days of observation

GLP compliance:

not specified

Test type:

standard acute method

Specific details on test material used for the study:

not specified

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age: adult
- Weight: 200 to 300 g
- Diet (ad libitum): purina® chow
- Water (ad libitum)

ENVIRONMENTAL CONDITIONS - air-conditioned room

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

DOSAGE PREPARATION
50 % aqueous suspensions of the salt was prepared and were given in a single dose by gavage.

Doses:

at least one dose level of >5000 mg/kg was given (element lanthanum only: >2450 mg/kg)(not clearly stated how many dose levels were used in the study)

No. of animals per sex per dose:

20 rats (assumed total number of rats; number of males and females were not stated and overall it is not clearly stated how many rats participitated in the study)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: all animals were observed for 10 d, but initial groups receiving a given compound were kept for 30 d to ascertain if any significant mortality occurred after day 10. However, the 10-d observation period was sufficient.

Statistics:

The LD50 values were obtained from ten day mortality data by using the log-probability method. No sex differences were noted and the LD50 value was therefore derived from the combined data on both sexes.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 450 mg/kg bw

Based on:

element

Remarks:

lanthanum

Remarks on result:

other: Effect based on lanthanum content (~ 49%)

Mortality:

All animals survived.

Clinical signs:

other: not specified

Gross pathology:

not specified

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rats; combined sexes): >5000 mg La2(SO4)3/kg bw (>2450 mg La/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, lanthanum sulfate is not acutely toxic via the oral route.

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

not specified

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

purity/stability of test item missing; number of male and female rats not stated; number of dose levels not clearly stated; body weight measurements and pathological findings missing; LD50 determination after 10 days of observation

GLP compliance:

not specified

Test type:

standard acute method

Specific details on test material used for the study:

not specified

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age: adult
- Weight: 200 to 300 g
- Diet (ad libitum): purina® chow
- Water (ad libitum)

ENVIRONMENTAL CONDITIONS - air-conditioned room

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

DOSAGE PREPARATION
50 % aqueous solutions of the salt was prepared and were given in a single dose by gavage.

Doses:

at least one dose of 4200 mg/kg was given (element lanthanum only: 2370 mg/kg)(not clearly stated how many dose levels were used in the study)

No. of animals per sex per dose:

24 rats (assumed total number of rats; number of males and females were not stated and overall it is not clearly stated how many rats participitated in the study)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: all animals were observed for 10 d, but initial groups receiving a given compound were kept for 30 d to ascertain if any significant mortality occurred after day 10. However, the 10-d observation period was sufficient.

Statistics:

The LD50 values were obtained from ten day mortality data by using the log-probability method. No sex differences were noted and the LD50 value was therefore derived from the combined data on both sexes.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 200 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 370 mg/kg bw

Based on:

element

Remarks:

lanthanum

Remarks on result:

other: Effect based on lanthanum content (~ 56%)

Mortality:

not specified

Clinical signs:

other: not specified

Gross pathology:

not specified

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rats; combined sexes): 4200 mg LaCl3/kg bw (~2370 mg La/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, lanthanum chloride is not acutely toxic via the oral route.

Reference 5

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: lack of details on test substance, no data available about the control group, no details available on the preparation of dosing solution and physical form of the administered compound.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (no further information)
- Age at study initiation: No data available.
- Weight at study initiation: 183-299 grams (males) and 158-204 grams (females).
- Fasting period before study: Animals were fasted overnight prior to treatment.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

No details available.

Doses:

1000, 1590, 2510, 3980, 6310, 10000, and 15900 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 14 days.
Frequency of observation in all animals: immediately after dosing, 1, 4 and 24 hours after dosing, and one daily during the total of 14 days observation period.
At the end of study, gross necroscopy was performed on all animals (animals which died during the study and on those sacrificed by chloroform overdose).

Statistics:

No data available.

Preliminary study:

Not performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 900 mg/kg bw

Based on:

test mat.

Mortality:

The fumed alumina did not cause mortality in males and females Sprague-Dawley rats after an acute oral exposure (gavage) to 1000, 1590, 2510, 3980, 6310, 10000 and 15900 mg/kg bw.

Clinical signs:

other: No toxic effects were noted in aluminium treated animals at doses from 1000 mg/kg to 10000 mg/kg. At dose 15900 mg/kg, clinical signs of depression, laboured respiration, and piloerection (males) were noted immediately after administration of the compou

Gross pathology:

No changes in gross pathology were noted at sacrifice.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute oral toxicity, no classification is required.

Executive summary:

An acute oral toxicity study comparable to OECD 401 was performed with fumed alumina in female and male rats. This study has been performed at the Hazelton Laboratories, Inc.. Fumed alumina was administered by a single oral gavage to seven groups of five males and five females per group at dose levels of 1000, 1590, 2510, 3980, 6310, 10000 and 15900 mg/kg bw after an overnight food withdrawal.

Parameters monitored during this study included mortality and clinical signs of possible intoxication.Clinical observations were performed on all animals immediately after dosing, at 1, 4 and 24 hours after dosing and daily for 14 days thereafter.

During the 14 days of the observation period, there was no mortality or clinical signs of intoxication related to aluminium oxide administration at dose range from 1000 mg/kg to 10000 mg/kg bw. 

Clinical signs of depression, laboured respiration, and piloerection (males) were noted immediately and hunched appearance was noted at 24 hours post-administration of the highest dose 15900 mg/kg. 

No significant sex differences were noted among animals in the sensitivity to the administered compound or during the recovery period. Animals appeared normal by day 7 (females) and day 8 (males).

Macroscopic examination at the end of the observation period did not reveal any aluminium-related changes of the internal organs of the aluminium treated animals compared to the control group.

Under the conditions of this study, the acute oral median lethal dose (LD50) of the fumed alumina is above 15900 mg/kg bw in both females and males rats.

Reference 6

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: lack of details on test substance; No details available on the preparation of dosing solution and physical form of the administered Al hydroxide

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute colony
- Age at study initiation: no data
- Weight at study initiation: 135 to 188 grams (males) and 93-116 grams (females).
- Fasting period before study: animals were fasted overnight prior to treatment.
- Housing: the rats were housed in groups of 5 in screen-bottom stainless-steel cages.
- Diet: animals were fed with stock diet, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1 °C
- Air changes (per hr): Well ventilated room (no other data available)

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Al oxide was prepared as 33% (w/v) aqueous suspension and administered by a single oral dose.
Treatment volume applied: 3 mL/100 g body weight.
Administered dose was equivalent to 10000 mg test substance per kg body weight.

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

Before dosing the rats were fasted overnight.
After treatment animals received stock diet and water ad libitum.
Duration of observation period for possible signs of intoxication: 14 days.
At the end of study (after 14 days of observations), autopsy was performed on all animals.

Statistics:

No data available.

Preliminary study:

Not performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

Aluminium oxide did not cause mortality in males and females (Wistar) rats after an acute oral exposure (gavage) to 10000 mg/kg bw.

Clinical signs:

other: No death occurred after the treatment. At dose 10000 mg/kg, no clinical signs of intoxication were observed during the post-administration observation period. Animals appeared healthy through the observation period.

Gross pathology:

Macroscopic examination of the exposed animals did not reveal any treatment–related gross alterations.

Other findings:

None.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute oral toxicity, no classification is required.

Executive summary:

An acute oral toxicity study was performed with aluminium oxide (granulated solid product, TBH) in both female and male rats.

This study has been performed at the Central Institute for Nutrition and Food Research, Germany.

Al₂O₃was administered by a single oral gavage to ten males and ten females per group at dose level of 10000 mg/kg bw after an overnight food withdrawal.

Parameters monitored during this study included mortality, clinical signs of possible intoxication, and changes in gross pathology.Clinical observations were performed on all animals during 14 days there the Al₂O₃administration.

During the 14 days of the observation period, there was no mortality or clinical signs of intoxication related to aluminium oxide administration at dose 10000 mg/kg bw. 

No significant sex differences were noted among animals in the sensitivity to the administered compound. 

Macroscopic examination at the end of the observation period did not reveal any changes of the internal organs associated with the aluminium treatment.

Reference 7

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Justification for type of information:

The solubility of aluminium lanthanum trioxide (AlLaO3) is low since dissolution of AlLaO3 in water resulted in La concentrations < 0.01 mg/L and Al concentrations < 0.03 mg/L after 34 days. The dissolution of AlLaO3 in water results in Al (3+) (=Al(H2O)6 (3+)) ions and La (3+) ions. Thus, the toxicological moieties of concern are aluminium and lanthanum ions. Thus, in the assessment of toxicity, data available for different aluminium and lanthanum substances are read-across since aluminium and lanthanum ions determine the toxicological potential of aluminium lanthanum trioxide, i.e. are the common toxicological moieties of concern. The effects of the substance aluminium lanthanum trioxide with regard to acute oral toxicity are predicted to be equal to the effects of Al (3+) ions and La (3+) ions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: lack of details on test substance

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute colony.
- Age at study initiation: no data
- Weight at study initiation: 285-360 grams (males) and 165-212 grams (females).
- Fasting period before study: yes, overnight prior to treatment.
- Housing: The rats were housed in groups of 5 in screen-bottom stainless-steel cages.
- Diet: Animals were fed with stock diet, ad libitum.
- Water: ad libitum
- Acclimation period: Not required.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1 °C
- Air changes (per hr): Well ventilated room (no other data available)

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Al oxide was prepared as 33% (w/v) aqueous suspension and administered as single oral dose.
Treatment volume applied: 3 mL/100 g body weight.
Administered dose was equivalent to 10000 mg test substance per kg body weight by gavage as a highest tolerable dose in one single oral dose.

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

Before dosing the rats were fasted overnight.
After treatment animals received stock diet and water ad libitum.
Duration of observation period for possible signs of intoxication: 14 days.
At the end of study (after 14 days of observations), gross necroscopy was performed on all animals.

Statistics:

No data available.

Preliminary study:

Not performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

Aluminium oxide did not cause mortality in males and females (Wistar) rats after an acute oral exposure (gavage) to 10000 mg/kg bw.

Clinical signs:

other: No death occurred after the treatment. At dose 10000 mg/kg, no clinical signs of intoxication were observed during the post-administration observation period. Animals appeared healthy through the observation period.

Gross pathology:

Macroscopic examination of the exposed animals did not reveal any treatment–related gross alterations.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute oral toxicity, no classification is required.

Executive summary:

An acute oral toxicity study comparable to OECD 401 with acceptable restrictions was performed with aluminium oxide (granulated solid product, TOF) in both female and male rats.

This study has been performed at the Central Institute for Nutrition and Food Research,.

Al₂O₃was administered by a single oral gavage to ten males and ten females per group at dose level of 10000 mg/kg bw after an overnight food withdrawal.

Parameters monitored during this study included mortality, clinical signs of possible intoxication, and changes in gross pathology. Clinical observations were performed on all animals during 14 days there the Al₂O₃administration.

During the 14 days of the observation period, there was no mortality or clinical signs of intoxication related to aluminium oxide administration at dose 10000 mg/kg bw. 

No significant sex differences were noted among animals in the sensitivity to the administered compound. 

 

Macroscopic examination at the end of the observation period did not reveal any changes of the internal organs associated with the aluminium treatment.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 652 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Data are read-across based on grouping of substances, i.e. aluminium oxide, lanthanum trioxide and aluminium lanthanum oxide, based on inertness and similar solubility or lack thereof (see category approach).

The acute oral toxicity of aluminum lanthanum trioxide is estimated based on the lowest acute toxicity estimates available from 3 studies of aluminium trioxide and 4 studies of lanthanum substances including lanthanum trioxide (2 studies), lanthanum chloride (1 study) and lanthanum sulfate (1 study). Acute toxicity estimates for aluminium trioxide range from > 10,000 mg/kg bw to > 15,900 mg/kg bw (all male and female rats) corresponding to > 5,200 mg Al/kg bw to > 8,268 mg Al/kg bw. Acute toxicity estimates for lanthanum trioxide, lanthanum chloride and lanthanum sulfate range from 4,200 mg/kg bw to > 10,000 mg/kg bw (all male and female rats) corresponding to 2,370 mg La/kg bw to > 3,500 mg La/kg.

The Acute toxicity estimate (ATE) of aluminium lanthanum trioxide is estimated with the following equation:

(ATE) of aluminium lanthanum trioxide = 100/(aluminium concentration/ATE aluminium + lanthanum concentration/ATE lanthanum)

ATE aluminium lanthanum trioxide = 100 % / (64.9% / 2870 mg/kg bw + 12.6% / > 5200 mg/kg bw)

ATE aluminium lanthanum trioxide = 3652 mg/kg bw

The acute oral toxicity of aluminum lanthanum trioxide (12.6% aluminium and 64.9% lanthanum) based on the lowest acute toxicity estimates available for aluminium and lanthanum is thus estimated with an LD50 of 3652 mg/kg bw. Thus, aluminium lanthanum trioxide is not acutely toxic via the oral route according to the Regulation (EC) No 1272/2008 and subsequent adaptations.

Justification for classification or non-classification

Acute oral toxicity

Aluminium lanthanum trioxide is not acutely toxic via the oral route according to the Regulation (EC) No 1272/2008 and subsequent adaptations.