Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-hydroxyethanesulphonate
EC Number:
213-037-4
EC Name:
Sodium 1-hydroxyethanesulphonate
Cas Number:
918-04-7
Molecular formula:
C2H6O4S.Na
IUPAC Name:
sodium 1-hydroxyethane-1-sulfonate
Details on test material:
Name of the test substance used in the study report: Acetaldehydbisulfit spezial

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age at study start: about 6 - 8 weeks
Mean body weight at study start: 185 +/- 15 g
The animals were identified by toe amputation.
The animals were offered a standardized animal laboratory diet and tap water ad libitum during the observation period.
The animals were accommodated in fully air-conditioned rooms (temperature 22 + 2°C, humidity 55 + 5%) with a light/dark rhythm of 12 hours.
They were housed in groupe of five in cages of Becker, type D III resp. MD III, without bedding.

Administration / exposure

Route of administration:
other: dust-aerosol test
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
Head-nose inhalation system; the animals are restrained in tubes and their snouts project into the inhalation chamber.
A mixture of dust and air was generated by means of dust metering equipment.
By means of a dust generator the substance to be tested was generated into a dust aerosol, which was passed into the inhalation system.
By means of an-exhaust air system the pressure ratios in the inhalation chamber were adjusted in such a way that the amount of fresh air was about 10% higher (excess pressure). This ensured that the mixture of test substance and air was not diluted by laboratory air in the breathing zones of the animals.
Duration of exposure:
4 h
Concentrations:
5.78 mg/l
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
After the exposure period the surviving animals were observed for 14 days.
The body weight of the animais was checked before the beginning of the test, after 7 days and at the end of the observation period and was presented graphically. Clinical symptoms were recorded each workday. Mortality was checked each day.
At the end of the 14-day observation period the animals were sacrificed by CO2 and were subjected to a grosspathological examination.
Statistics:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.8 mg/L air
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: During exposure: snout wiping After exposure: liquid up to reddened nasal secretion; the animals were without findings after one day.
Body weight:
Male animals: 191 g at study start; 278 g after 14 days
Female animals: 181 g at study start; 212 g after 14 days
No differences between control and exposure groups.
Gross pathology:
Sacrificed animals: nothing abnormal detected

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met