Reaction product of 1-chloro-2,3-expoxypropane, sodium hydroxide, sodium carbonate and water

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:

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

Test material information

Constituent 1

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

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.