Registration Dossier
Registration Dossier
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EC number: 238-289-2 | CAS number: 14338-82-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study, incl. certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Dibutyl methylenedithiodi(acetate)
- EC Number:
- 238-289-2
- EC Name:
- Dibutyl methylenedithiodi(acetate)
- Cas Number:
- 14338-82-0
- Molecular formula:
- C13H24O4S2
- IUPAC Name:
- butyl 2-({[(2-butoxy-2-oxoethyl)sulfanyl]methyl}sulfanyl)acetate
- Test material form:
- other: liquid
- Details on test material:
- Lot#: 23017
Assay: 97.9 % area GC FID
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar HsdRccHan
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 5 female rats, 8 to 12 weeks old, body weight 144-185 g
Housing conditions:
Macrolon cages with Altromin saww fiber bedding
Free access to tap water and Altromin 1324 maintenance diet (rat, mouse)
light cicle 12/12 h artificial
Air change 10/h
temperature 19 - 25°C, 45 - 65% rel. humidity
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- 24 h before test fur was removed from the dorsal area of the trunk by clipping. Care was taken to avoid abrading the skin.
Test mat was applied as single dose uniformly over an area which was at least 10% of the total body surface. Test material was fixed by gauze dressing and non irritating tape.
Exposure was 24 h, at the end of exposure residual test material was removed by using tap water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
Results and discussion
- Preliminary study:
- 1 animal 2000 mg/kg bw, no effects
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no effect
- Mortality:
- no
- Clinical signs:
- other: no signs
- Gross pathology:
- no findings
- Other findings:
- no findings
Any other information on results incl. tables
cf attached background material
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Considering the reported data of this dermal toxicity test it can be stated tha the test material methylenbis(butyl thioglycolate) has no acute dermal toxic or irritant characteristics.
Acc. to the criteria of Globally Harmonized Classification System (GHS) the test material needs no classification for acute percunateous toxicity or dermal irritation
The LD50 was determined to be >2000 mg/kg bodyweight. therfore the test material is unclassified acc. to the criteria of ANNEX VI to Directive 2001/59/EC.
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