Registration Dossier
Registration Dossier
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EC number: 500-110-3 | CAS number: 50586-59-9 1 - 6.5 moles ethoxylated
Acute Toxicity: dermal
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:
- other: Study was conducted in accordance to GLP and OECD guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated
- EC Number:
- 500-110-3
- EC Name:
- Propylidynetrimethanol, ethoxylated
- Cas Number:
- 50586-59-9
- Molecular formula:
- C3H5(CH2O(C2H4O)nH) sum of n: >1 - <6.5 mol EO
- IUPAC Name:
- Propylidynetrimethanol, ethoxylated
- Details on test material:
- Propylidenetrimethanol, ethoxylated mw 356; colourless liquid; content of test item: 100 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, Horst, netherlands
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation:283 g - 297 g (male); 215 g - 227 g (female)
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shorn skin
- % coverage: approx. 10% of the total body surface area
REMOVAL OF TEST SUBSTANCE
After the 24-hour contact period, treated skin and surrounding hair wiped with water using soap - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
During and after exposure, animals were observed for signs of toxicity several times on the day of application; at least once each workday for 14 days. At the end of the study, all animals were killed and subject to gross necropsy.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths
- Clinical signs:
- other: No signs of systemic toxicity
- Gross pathology:
- No abnormalities were noted on necropsy
Applicant's summary and conclusion
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Wistar rat was found to be greater than 2000 mg/kg bodyweight.
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