Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
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:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
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 = 1-Hydroxy-1-ethyl-natriumsulfonat

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Acclimatization period: at least one week
Animals with a comparable weight were used.
Age at study start: about 12 weeks
Five animals per cage (type: stainless steel wire mesh cages, DK-III).
The animals were identified via groups using cage cards.
Room temperature: 20 - 26!C
Relative humidity: 45 - 75%
Day/night rhythm: 12 h light and 12 h darkness
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum. 16 hours before administration food deprivation (but water was available ad libitum).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The aqueous preparation (solution) corresponds to the physiological media.
Concentrations used were 21.5, 26.1, 31.6, 38.3 and 46.4% (G/V).
Administration volume: 10 ml/kg
Doses:
2150, 2610, 3160, 3830, 4640 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period: 14 days
Recording of signs and symptoms: > 15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after administration, then once each working day. Check of moribund or dead animals twice each working days and once on public holidays.
Necropsy: 16 hours before killing with CO2 food deprivation; then necropsy with macroscopic-pathological examination. Necropsy of all animals that died as soon as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 402 mg/kg bw
Mortality:
Male animals: 2150, 2610 and 3160 mg/kg: 0/5 after 14 days; 3830 mg/kg: 3/5 after 14 days; 4640 mg/kg: 5/5 after 14 days
Femalea nimals: 2150 mg/kg: 0/5 after 14 days; 2610 and 3160 mg/kg: 3/5 after 14 days; 3830 and 4640 mg/kg: 5/5 after 14 days
Clinical signs:
Dyspnea, gasping, apathy, abnormal position, twitching, spastic gait, ruffled fur, ptosis, falling backwards, poor general state
Body weight:
Mean body weight male animals: 186 g at study start, 284 g after 11 days
Mean body weight female animals: 170 g at study start, 223 g after 11 days
Gross pathology:
Animals that died: Lung congestion, liver: passive hyperemia
Sacrificed animals: nothing abnormal detected.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria