Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
other: publication
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study seems to be conducted scientifically reasonable, but too few information on observations and results are given

Data source

Reference
Reference Type:
publication
Title:
"The toxicology of glycidol and some glycidyl ethers"
Author:
Hine, Kodoma, Wellington, Dunlap, Anderson
Year:
1956
Bibliographic source:
Hine, C. H., J. K. Kodoma, J. S. Wellington, M. K. Dunlap, H. H. Anderson: "The toxicology of glycidol and some glycidyl ethers", Arch. Ind. Health 14, 250 (1956)

Materials and methods

Principles of method if other than guideline:
Application of 0.2 ml isopropyl glycidyl ether (about 90 mg/kg) to the skin of a rabbit, once daily, 5 times weekly on a total of 7 days until the degree of eschar formation at the site made further applications undesirable, or the animals showed signs of systemic toxicity.
GLP compliance:
no
Remarks:
conducted prior to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl isopropyl ether
EC Number:
223-672-9
EC Name:
2,3-epoxypropyl isopropyl ether
Cas Number:
4016-14-2
Molecular formula:
C6H12O2
IUPAC Name:
2-[(propan-2-yloxy)methyl]oxirane
Test material form:
not specified
Details on test material:
No details available

Test animals

Species:
rabbit
Strain:
other: California Albino or New Zealand White rabbit
Sex:
not specified
Details on test animals or test system and environmental conditions:
No details available
TEST ANIMALS
- Source: rabbitry at Point Reyes, Calif., or the Gilroy laboratory

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on exposure:
TEST SITE
- Area of exposure: back
- % coverage: 1cm in diameter
- Time intervals for shavings or clipplings: The fur was closely clipped from the backs of albino rabbits at least 20 hours before the tests were begun. When at was necessary to clip regrowth of fur during the experiment, a period of at least 15 hours was allowed for healing of possible injury before further applications were made.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The material was removed at the end of one hour by wiping with soft laboratory tissues followed by tissues moistened with acetone.
- Time after start of exposure: 1h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
7 days
Frequency of treatment:
5 times weekly on a total of 7 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0.2 ml (about 90 mg/kg)
Basis:
no data
No. of animals per sex per dose:
six males
Control animals:
not specified
Details on study design:
No details available
Positive control:
No details available

Examinations

Observations and examinations performed and frequency:
No details available
Sacrifice and pathology:
No details available
Other examinations:
No details available
Statistics:
No details available

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
skin erythema
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
reduction in body weight gain
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
No details available

Effect levels

Dose descriptor:
other: irritation index
Effect level:
2.2 other: no unit
Based on:
test mat.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The study could be used to support the data of the key study via oral application.
Executive summary:

Application of 0.2 ml isopropyl glycidyl ether (about 90 mg/kg) to the skin of a rabbit, once daily, 5 times weekly on a total of 7 days caused a reduction in body weight gain and skin erythema [Hine, C. H., J. K. Kodoma, J. S. Wellington, M. K. Dunlap, H. H. Anderson: "The toxicology of glycidol and some glycidyl ethers", Arch. Ind. Health 14, 250 (1956)]