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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
September 1993 to March 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium 4-methylbenzenesulfinate
EC Number:
700-509-4
Cas Number:
19294-29-2
Molecular formula:
C7H7KO2S
IUPAC Name:
Potassium 4-methylbenzenesulfinate
Details on test material:
- Name of test material (as cited in study report): CGA 311117 tech.
- Physical state: solid
- Purity: 93.8%
- Lot/batch No.: V.24-30-10
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Initial body weight range: 180 - 237g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, std soft wood bedding
- Diet (e.g. ad libitum): NAFAG 890 Tox ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12hour/day light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% w/v CMC in 0.1% w/v aqueous polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000mg/kg
- Amount of vehicle (if gavage): 10ml/kg body weight
Doses:
One single dose by gastric intubation
No. of animals per sex per dose:
5 per sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately before administration, then on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Mortality:
No mortalities occured in this study
Clinical signs:
2000 mg/kg, males
Admin day Days after
1hr 3 hr 5hr 1 2 3 4 5 6 7
1-5 piloerection + ++ ++ + +
1-5 hunched post + + + +
1-5 dyspnea + +

2000 mg/kg, females
Admin day Days after
1hr 3 hr 5hr 1 2 3 4 5 6 7
1-5 piloerection + + + +
1-5 hunched post + + +
1-5 dyspnea + + +

Key

+ = slight; ++ = moderate; +++ = severe
Hunched post. = hunched posture
Body weight:
180 - 237 g
Gross pathology:
No deviations from normal morphology were found in all animals

Any other information on results incl. tables

           
           
           
           
           
           
           
           
           
           
           
           
           
           
           

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Upon an oral administration and a 14 day post treatment observation period, no mortality occured and all animals recovered from observed effects within 2 -3 days. At necropsy, no deviations from normal morphology were observed in all animals.

Therefore LD50 value set at >2000mg/kg both sexes.

Substance deemed to be relatively harmless.