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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
No further information available.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrothiophene 1,1-dioxide
EC Number:
204-783-1
EC Name:
Tetrahydrothiophene 1,1-dioxide
Cas Number:
126-33-0
Molecular formula:
C4H8O2S
IUPAC Name:
1λ⁶-thiolane-1,1-dione
Constituent 2
Reference substance name:
Sulfolane
IUPAC Name:
Sulfolane
Details on test material:
- Name of test material (as cited in study report): Tetrahydrothiophene-1,1-dioxide
- Analytical purity: 95%
- Impurities: 5% water
- Supplied by Shin Nippon Rika, Lot No. 0007

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5 weeks of age
- Weight at study initiation: 122-138 g for males; 107-120 g for females

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No information is available.
Doses:
892, 1204, 1626, 2195, 2963, and 4000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was weighed immediately prior to treatment, the day and thereafter 1, 3, 7 and 14 days after treatment. The rats were observed periodically during the two-week post-treatment observation period.
- Necropsy of survivors performed: yes
Statistics:
LD50 was calculated by Van der Waerden method

Results and discussion

Preliminary study:
No information is available.
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 006 mg/kg bw
Remarks on result:
other: 1783 – 2256
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 130 mg/kg bw
Remarks on result:
other: 1844 - 2460
Mortality:
Males: 4/5, 5/5, and 5/5 at 2195, 2963, and 4000 mg/kg, respectively. Females: 3/5, 5/5, and 5/5 at 2195, 2963 and 4000 mg/kg, respectively.
Clinical signs:
other: Males at >/=1626 mg/kg: convulsions, decreased locomotor activity, ptosis, salivation, piloerection, chromodacryorrhea and perineal region soiling with urine. [CONFIRM THAT THESE EFFECTS REFER TO MALES] Females at >/= 1626 mg/kg: decreased locomotor act
Gross pathology:
Dead animals showed hemorrhagic black spots in their glandular stomach mucosa at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 in male and female rats were 2006 and 2130 mg/kg, respectively.
Executive summary:

A single oral dose of sulfolane was administered to rats by gavage at doses of 0, 892, 1204, 1626, 2195, 2963, and 4000 mg/kg. The acute oral LD50 in male and female rats were established at 2006 and 2130 mg/kg, respectively.