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EC number: 939-516-4 | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 953
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Test material was applied to rabbit skin for 8 hours/day, 5 days/week for 45 weeks. The Draize method was used to evaluate the skin. Body weights, urinalysis and selected tissues were examined histopathologically.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Test material form:
- not specified
- Details on test material:
- purity 99.5% for synthetic and natural glycerine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- other: No occlusion at the two lower dose levels and occlusion at the two upper dose levels.
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 hours/day
- Frequency of treatment:
- 5 days/week for 45 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5-4.0 ml/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 6/dose level
- Control animals:
- not specified
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- other: 4.0 ml/kg
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No effects noted in 90 day study at dose levels as high as 4.0 ml/kg.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No signs of local irritation after 90 days of application.
OTHER EFFECTS: no treatment related effects on the other parameters measured.
Applicant's summary and conclusion
- Conclusions:
- There were no effects noted in rabbits dosed 8 hours/day, 5 days/week for 45 weeks with dose levels as high as 4.0 ml/kg.
- Executive summary:
The effects following repeated dermal application of glycerin were examined. There were no local or systemic effects noted in rabbits dosed 8 hours/day, 5 days/week for 45 weeks with dose levels as high as 4.0 ml/kg. Using a density of 1.2611 g/cm3 at 20 °C, a dose of 4.0 ml/kg corresponds to 5040 mg/kg/day.
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