Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically valid study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study predates OECD guidelines. However, it follows the principles of a OECD guideline 403 limit test.
GLP compliance:
no
Remarks:
Study performed prior to implementation of GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dimethyl 5-sulphonatoisophthalate
EC Number:
223-578-8
EC Name:
Sodium dimethyl 5-sulphonatoisophthalate
Cas Number:
3965-55-7
Molecular formula:
C10H10O7S.Na
IUPAC Name:
sodium 3,5-bis(methoxycarbonyl)benzenesulfonate
Test material form:
other: solid

Test animals

Species:
rat
Strain:
other: ChR-CD

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Details on inhalation exposure:
> 75 % of particles were < 3µm in diam.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
32 mg/lit +/- 20 %
No. of animals per sex per dose:
2 animals per dose
Details on study design:
- Observation period: at least 9 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC0
Effect level:
>= 32 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no mortality
Clinical signs:
other: Discomfort during exposure
Body weight:
no data
Gross pathology:
None of the pathological changes attributable to treatment found 9 days after exposure

Applicant's summary and conclusion

Conclusions:
Under the conditions of the present study the approximate lethal concentration is > 32 mg/L.
Executive summary:

In an acute inhalation toxicity study ( Haskell Laboratory for Toxicology and Industrial Medicine, 1959, non-GLP) two rats were treated with Sodium Sulfo Dimethylisophtalate dust in concentrations of 32 mg/L +/- 20 % for 4 hours by inhalation. More than 75 % of the dusts particles had a size < 3µm in diameter. As clinical signs discomfort during exposure were noted. Mortality did not occur within the 9 -day observation period. At nercopsy none of the pathological changes were attributable to treatment. The results of the study indicate a LC0 of > 32 mg/L.