Reaction mass of disodium sulphide and sodium carbonate and sodium hydroxide

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

For this endpoint, an analysis based on the components is performed. Based on SIDS report on Sodium carbonate and sodium hydroxide, no repeated toxicity has to be taken into account whatever the route of administration. A NOAEC has been derived for Na2S, on its registration dossier, based on a 90 days inhalation studies on two rat strains and mice (Dorman et al, 2004, Respiratory tract toxicity of inhaled hydrogen sulphide in fischer-344 rats, Sprague-Dawley rats and B6C3F1 mice following subchronic (90 day) exposure). Based on this study the NOAEC considered for the multi-constituent is derived from the sulphide registration dossier: 80 ppm (410 mg/m3).

Data source

Reference

Reference Type:

publication

Title:

Respiratory tract toxicity of inhaled hydrogen sulphide in fischer-344 rats, Sprague-Dawley rats and B6C3F1 mice following subchronic (90 day) exposure

Author:

Dorman et al

Year:

2004

Bibliographic source:

Toxicology and Applied Pharmacology

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: No guideline follow

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen sulphide

EC Number:

231-977-3

EC Name:

Hydrogen sulphide

Cas Number:

7783-06-4

Administration / exposure

Route of administration:

inhalation: vapour

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Effect level:

80 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no relevant alterations in haematological indices, serum chemistries or gross pathology

Target system / organ toxicity

Critical effects observed:

no

Lowest effective dose / conc.:

80 ppm

System:

respiratory system: upper respiratory tract

Organ:

not specified

Treatment related:

not specified

Dose response relationship:

not specified

Any other information on results incl. tables

The 80 ppm correspond to approximatively 410 mg/m3 of sodium sulfide

Applicant's summary and conclusion

Conclusions:

The NOAEC used and estimated for the multi-constituent is equal to 80 ppm (equivalent to approximately 410 mg/m3)