Aluminium sulphate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated 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: Reliable with restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum chloride, basic

EC Number:

215-477-2

EC Name:

Aluminum chloride, basic

Cas Number:

1327-41-9

IUPAC Name:

aluminum trichloride

Constituent 2

Reference substance name:

Aluminium chlorohydrate

IUPAC Name:

Aluminium chlorohydrate

Details on test material:

-Name of test material : Aluminium chlorohydrate
-EC name: dialuminium chloride pentahydroxide
- CAS mumber: 12042-91-0
- EC number: 234-933-1
- Molecular formula : Al2Cl(OH)5
- Molecular weight : 174.452776 g/mol
- Smiles notation – Al]([Al](O)(O)Cl)(O)(O)O
- InChI notation- 1/2Al.ClH.5H2O/h;;1H;5*1H2/q2*+3;;;;;;/p-6/rAl2ClH5O5/c3-1(4,5)2(6,7)8/h4-8H
- Structural formula attached as image file : see Fig.2
- Substance type:inorganic
- Physical state: solid
- Density: 1,35g/cm3
- Melting point: >100 °C
- Boiling point: 110-115 °C
- Solubility in water: 500 g/l at 20 o C

Test animals

Species:

hamster

Strain:

other: Golden Syrian

Sex:

male/female

Details on test animals or test system and environmental conditions:

Hamster (Golden Syrian)

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: alchlor (a propylene glycol complex of aluminum chlorhydrate)

Details on inhalation exposure:

A 3-day 4 or 6 hr/d exposure to 31 or 33 mg Al/m3 in hamsters
A 3-day 4 or 6 hr/d exposure to 3 or 7 mg Al/m3 in hamsters

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

3 d

Concentrations:

A 3-day 4 or 6 hr/d exposure to 31 or 33 mg Al/m3
A 3-day 4 or 6 hr/d exposure to 3 or 7 mg Al/m3

Control animals:

yes

Details on study design:

Respiratory effects typically associated with inhalation of particulates and lung overload have been observed in animals. The pulmonary toxicity of alchlor (a propylene glycol complex of aluminum chlorhydrate), a common component of antiperspirants, was examined in hamsters in a series of studies conducted by Drew et al. (1974).
A 3-day exposure to 31 or 33 mg Al/m3 resulted in moderate-to-marked thickening of the alveolar walls due to neutrophil and macrophage infiltration and small granulomatous foci at the bronchioloalveolar junction (a likely site of particulate deposition). A decrease in the severity of the pulmonary effects was observed in animals killed 3, 6, 10, or 27 days after exposure termination.
Similar pulmonary effects were observed in rabbits exposed to 42 mg Al/m3 for 5 days (Drew et al. 1974). Significant increases in absolute lung weights have been observed in hamsters exposed for 3 days to ≥7 mg Al/m3 (no effects were observed at 3 mg Al/m3) and in rabbits exposed to 43 mg Al/m3 for 5 days (no effects were observed in rabbits exposed to 48 or 39 mg Al/m3 for 1 or 4 days, respectively).

Results and discussion

Preliminary study:

A 3-day exposure to 31 or 33 mg Al/m3 resulted in moderate-to-marked thickening of the alveolar walls due to neutrophil and macrophage infiltration and small granulomatous foci at the bronchioloalveolar junction (a likely site of particulate deposition). A decrease in the severity of the pulmonary effects was observed in animals killed 3, 6, 10, or 27 days after exposure termination. Significant increases in absolute lung weights have been observed in hamsters exposed for 3 days to ≥7 mg Al/m3 (no effects were observed at 3 mg Al/m3)

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

other: NOAEL

Effect level:

3 mg/m³ air

Based on:

test mat.

Exp. duration:

3 d

Remarks on result:

other: (No effects were observed at 3 mg Al/m3)

Effect levels 2

Sex:

male

Dose descriptor:

other: LOAEL

Effect level:

7 mg/m³ air

Based on:

test mat.

Exp. duration:

3 d

Remarks on result:

other: Increases in absolute lung weights have been observed in hamsters exposed for 3 days to ≥7 mg Al/m3

Effect levels 3

Sex:

male

Dose descriptor:

other: LOAEL

Effect level:

10 mg/m³ air

Based on:

test mat.

Exp. duration:

3 d

Remarks on result:

other: (approximately 24% increased lung weight)

Effect levels 4

Sex:

male/female

Dose descriptor:

other: LOAEL

Effect level:

31 mg/m³ air

Based on:

test mat.

Exp. duration:

3 d

Remarks on result:

other: (alveolar wall thickening and increased number of macrophages and heterophils)

Effect levels 5

Sex:

male/female

Dose descriptor:

other: LOAEL

Effect level:

43 mg/m³ air

Based on:

test mat.

Exp. duration:

3 d

Remarks on result:

other: (alveolar wall thickening, increased number of macrophage; 65% increase in lung weight)

Mortality:

No

Clinical signs:

other: A 3-day exposure to 31 or 33 mg Al/m3 resulted in moderate-to-marked thickening of the alveolar walls due to neutrophil and macrophage infiltration and small granulomatous foci at the bronchioloalveolar junction (a likely site of particulate deposition).

Body weight:

Increases in absolute lung weights (13% increased lung weight) have been observed in hamsters exposed for 3 days to ≥7 mg Al/m3

Gross pathology:

A decrease in the severity of the pulmonary effects was observed in animals killed 3, 6, 10, or 27 days after exposure termination.

Other findings:

Pulmonary effects were observed in rabbits (New Zealand) exposed to 42 mg Al/m3 for 5 days .
Significant increases in absolute lung weights have been observed in rabbits (New Zealand) exposed to 43 mg Al/m3 for 5 days (no effects were observed in rabbits exposed to 48 or 39 mg Al/m3 for 1 or 4 days, respectively).

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information increases in absolute lung weights (13% increased lung weight) have been observed in hamsters exposed for 3 days to ≥7 mg Al/m3 Criteria used for interpretation of results: EU

Conclusions:

increases in absolute lung weights (13% increased lung weight) have been observed in hamsters exposed for 3 days to ≥7 mg Al/m3

Executive summary:

Respiratory effects typically associated with inhalation of particulates and lung overload have beenobserved in animals. The pulmonary toxicity of alchlor (a propylene glycol complex of aluminumchlorhydrate), a common component of antiperspirants, was examined in hamsters.

A 3-day exposure to 31 or 33 mg Al/m3 resulted in moderate-to-marked thickening of the alveolar walls due to neutrophil and macrophage infiltration and small granulomatous foci at the bronchioloalveolar junction (a likely site of particulate deposition). A decrease in the severity of the pulmonary effects was observed in animals killed 3, 6, 10, or 27 days after exposure termination.

Similar pulmonary effects were observed inrabbitsexposed to 42 mg Al/m3 for 5 days.

Significant increases in absolute lung weights have been observed in hamsters exposed for 3 days to≥7mg Al/m3 (no effects were observed at 3 mg Al/m3) and in rabbits exposed to 43 mg Al/m3 for 5 days (no effects were observed in rabbits exposed to 48 or 39 mg Al/m3 for 1 or 4 days, respectively).

I