Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
other: Dyspnea, gasping, apathy, abnormal position, twitching, spastic gait, ruffled fur, ptosis, falling backwards, poor general state
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