Calcium sulphidoacetate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-07 - 2008-05-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Federal State Authority, North Rhine-Westphalia, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium sulphidoacetate

EC Number:

249-881-5

EC Name:

Calcium sulphidoacetate

Cas Number:

29820-13-1

Molecular formula:

C2H4O2S.Ca x 3 H2O

IUPAC Name:

calcium 2-sulfanidylacetate

Constituent 2

Reference substance name:

CaTG

IUPAC Name:

CaTG

Test material form:

aerosol dispenser: not specified

Remarks:

migrated information: aerosol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Analytical verification of test atmosphere concentrations:

yes

Remarks:

CaTG aerosol sampled by gravimetric analysis was eluted from the filter and then determined by HPLC.

Duration of exposure:

4 h

Concentrations:

Four groups of rats were nose-only exposed to a solid aerosol in concentrations of 483, 1022, 2208, and 2729 mg/m3 air.

No. of animals per sex per dose:

5

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 729 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

Mortality did not occur in any concentration-dependent manner. The particle size distribution was not essentially different between groups with mortality. The LC50 was greater than 2729 mg/m3. No animals died at 483 mg/L (0/10 animals, 4 h exposure).

Clinical signs:

other: The signs of importance for the toxicological evaluation of the highest dose group can be qualitatively described as follows: bradypnea, labored breathing patterns, stridor, motility reduced, flaccidity, piloerection, hair-coat ungroomed, nose reddened, a

Body weight:

Comparison between control and exposure groups revealed consitent, concentration-dependent decrease in body weights.

Gross pathology:

Findings of toxicological importance and for toxicological evaluation can be summarized as follows:
Animals sacrificed at the end of the observation period: The macroscopic findings were essentially indistinguishable amongst exposure and control groups.
Animals succumbing during the observation period: nose-/muzzle area: red encrustations with somewhat occlude nostrils, trachea with white foamy content, lung less collapsed and with dark-red discolorations, gastrointestinal tract: black-red focal discolorations of mucosa and dark-red content in the lumen.

Other findings:

Statistical comparisons between the control and the exposure groups revealed significant changes in body temperature in groups 3 and above.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The aerosolized CaTG (solid aerosol, dry powder) proved to have a low acute inhalation toxicity in rats. Thus, the LC50 is greater than 2729 mg/m3. However, the observed signs demonstrated that the respirable dust of this test substance (in its micronized form) may cause marked and prolonged respiratory tract irritation.

Executive summary:

A study on the acute inhalation toxicity of CaTG on rats has been conducted in accordance with OECD Guideline No. 403. Mortality occurred in a few rats at 1022 mg/m³and above. However, any concentration-dependence or particular sex-dependence was not observed. The maximum technically achievable concentration was 2729 mg/m³. The exposure to this exposure level caused lingering and pronounced irritant effects in the upper and lower respiratory tract. Mortality is considered to be linked to acute lung edema. Due to the absence of concentration-dependent changes in particle size, the LC₅₀is greater than the maximum technically attainable concentration. Due to technical aspects as well as animal welfare considerations, the testing of CaTG at around 3000 mg/m³is considered to meet the criteria of limit-test of contemporary testing guidelines.