Registration Dossier
Registration Dossier
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EC number: 500-041-9 | CAS number: 25723-16-4 1 - 6.5 moles propoxylated
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Propylidynetrimethanol, propoxylated
- EC Number:
- 500-041-9
- EC Name:
- Propylidynetrimethanol, propoxylated
- Cas Number:
- 25723-16-4
- Molecular formula:
- C3H5(CH2OR)3 R= (C2H3(CH3)O)nH sum of n: >1 - <6.5 mol PO
- IUPAC Name:
- Propylidynetrimethanol, propoxylated
- Details on test material:
- Propylidenetrimethanol, propoxylated mw 310; clear,
colourless, viscous liquid; purity not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: least 200 g
- Housing: Individually during exposure and in groups of 5 by sex for the remainder of the study period
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
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
- Type of wrap if used: Self adhesive bandage
REMOVAL OF TEST SUBSTANCE
After the 24 h contact period, treated skin and surrounding hair were wiped with distilled water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No signs of systemic toxicity were observed.
- Gross pathology:
- No abnormalities were noted on necropsy.
Any other information on results incl. tables
Additional data supporting the information is attached below under 'Attached background material'.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The acute dermal LD50 in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bw.
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