Registration Dossier

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:
1953

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
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
purity 99.5% for synthetic and natural glycerine

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.