Aluminium sulphate

Specific investigations: other studies

Administrative data

Endpoint:

cytotoxicity

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:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Method: Investigations of the accumulation and effect of desulphur Gypsum on the organism, particularly the lungs,following intratracheal application.

GLP compliance:

not specified

Type of method:

in vivo

Endpoint addressed:

repeated dose toxicity: inhalation

genetic toxicity

Test material

Test material information

Constituent 1

Reference substance name:

Calcium sulfate

EC Number:

231-900-3

EC Name:

Calcium sulfate

Cas Number:

7778-18-9

IUPAC Name:

calcium sulfate

Constituent 2

Reference substance name:

calcium sulphate

IUPAC Name:

calcium sulphate

Details on test material:

- Name of test material: Calcium sulfate
- CAS number :7778-18-9
- EC Number: 231-900-3
- Molecular formula (if other than submission substance): CaSO4
- Molecular weight (if other than submission substance): 136.14 g/mol
- Smiles notation (if other than submission substance): [Ca+2].[O-]S([O-])(=O)=O
-InChl (if other than submission substance):=1/Ca.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Appearance: white solid
- Density -2.96 g/cm3)
- Melting point-1460 °C
- Solubility in water - 2.1 g/L (20 °C
- Synonyms: Plaster of Paris, Drierite,, Gypsum

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Long-term investigations have been carried out on Wistar rats for up to 18 months.

Administration / exposure

Route of administration:

intratracheal

Vehicle:

unchanged (no vehicle)

Details on exposure:

Long-term investigations have been carried out on Wistar rats for up to 18 months. Changes in lung tissue indicate unspecific bronchiolitis present also in controls. No foreign body accumulation would be observed in lung tissue or in hilus lymph nodes. A diffuse increase in the interstitial connective tissue was not proven. A cytotoxicological effect could not be attributed to gypsum.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

18 months.

Frequency of treatment:

daily

Post exposure period:

NR

No. of animals per sex per dose:

NR

Control animals:

yes, concurrent no treatment

Examinations

Examinations:

Changes in lung tissue indicate unspecific bronchiolitis present also in controls. No foreign body accumulation would be observed in lung tissue or in hilus lymph nodes.

Results and discussion

Details on results:

Long-term investigations have been carried out on Wistar rats for up to 18 months. Changes in lung tissue indicate unspecific bronchiolitis present also in controls. No foreign body accumulation would be observed in lung tissue or in hilus lymph nodes. A diffuse increase in the interstitial connective tissue was not proven. A cytotoxicological effect could not be attributed to gypsum.

Applicant's summary and conclusion

Conclusions:

Long-term investigations have been carried out on Wistar rats for up to 18 months. Changes in lung tissue indicate unspecific bronchiolitis present also in controls. No foreign body accumulation would be observed in lung tissue or in hilus lymph nodes. A diffuse increase in the interstitial connective tissue was not proven. A cytotoxicological effect could not be attributed to gypsum.