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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Principles of method if other than guideline:
Directive 84/449/EEC. No further information available.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sulfolane
- Physical state: Liquid, clear pale yellow
- Analytical purity: 97.4%
- Impurities: 2.6% water

Test animals

Species:
rat
Strain:
other: Crl:CD.BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K., Ltd.
- Age at study initiation: At least 7-8 weeks
- Weight at study initiation: mean Not reported
- Fasting period before study: Overnight
- Housing: 1-3 rats in stainless steel wire-mesh cages
- Diet: LAD 1, Special Diets Services, Ltd. ad libitum, except for pre-dose fast
- Water: Tap water ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 – 23°C
- Humidity: 30 – 70%
- Air changes (per hr): Not reported
- Photoperiod: 12 hrs dark / 12hrs light


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test Site
- Type of wrap if used: a gauze dressing (approx. 6 x 8 cm) covered with waterproof adhesive tape.

Removal of Test Substance
- Washing (if done): with warm dilute detergent solution
- Time after start of exposure: 24 hours

Test Material
- Amount(s) applied (volume or weight with unit): 1.59 mL/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours.
Doses:
2000 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: observations made at least six times on the day of dosing and twice daily thereafter for the remainder of the study. Body weights were measured prior to dosing, and thereafter on Day 1, 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
Not needed

Results and discussion

Preliminary study:
No information is available.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
The majority of rats showed staining (yellow) of the anogenital fur and one rat showed an unkempt appearance on Day 2 only. Erythema or discoloration (yellow) of the sites of application of the test material were common after removal of the dressings on Day 2. All dermal changes resolved by Day 4.
Body weight:
All rats had gained weight relative to their Day 1 body weights by the end of the first and second weeks of the 14-day observation period.

Gross pathology:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal rat LD50 of sulfolane was greater than 2000 mg/kg. No deaths were observed.

Executive summary:

Undiluted sulfolane at a dose of 2000 mg/kg was applied to the skin of male and female Sprague-Dawley rats for 24 hours by an occlusive patch. There were no deaths. The acute dermal LD50 of sulfolane in rats is greater than 2000 mg/kg.