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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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 activity

Females at >/= 2195 mg/kg: convulsions, ptosis, salivation, piloerection, chromodacryorrhea, perineal soiling with urine. [CONFIRM THAT THESE EFFECTS REFER TO FEMALES]

Body weight:
Reduced body weights in all treated dose groups compared to controls on the day after dosing.
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.