Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: dermal
Remarks:
other: 7 days
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment (The study was performed before the establishment of GLP and OECD guidelines)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The toxicology of Glycidol and some Glycidyl Ethers.
Author:
Hine CH et al.
Year:
1956
Bibliographic source:
Report, Department of Pharmacology and Experimental Therapeutics, University of California School of Medicine, San Francisco. Cited in OECD SIDS (SIAM 25, October 2007, Helsinki)
Reference Type:
publication
Title:
The toxicology of Glycidol and some Glycidyl Ethers.
Author:
Hine CH, Kodama JK, Wellington JS, Dunlap MK and Anderson HH
Year:
1956
Bibliographic source:
A.M.A. Archives of Industrial Health. 14: 250-264. Cited in OECD SIDS (SIAM 25, October 2007, Helsinki)
Reference Type:
publication
Title:
The toxicology of glycol and some glycidyl ethers.
Author:
Shell Chemical Company
Year:
1956
Bibliographic source:
TSCATS, OTS0523687, New Doc ID 40-5640496, Date produced 3/18/56.

Materials and methods

Principles of method if other than guideline:
0.2 ml of test material was applied undiluted daily (except weekends) until the degree of eschar formation made further applications undesirable or the animals showed signs of systemic toxicity. The exposure was under occlusive conditions and the test patch was removed 1 h after each application.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Allyl Glycidyl Ether

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Simonson laboratory in Gilroy, California
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): standards rabbit pellets

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: 1 cm2
- Time intervals for shavings or clipplings: hairs were closely clipped at least 24 h before the tests were made

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the material was removed by wiping with soft tissue followed by tissues moistened with acetone
- Time after start of exposure: 1 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
Duration of treatment / exposure:
7 days
Frequency of treatment:
1 h daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.2 ml (equivalent to 194 mg/rat)
Basis:

No. of animals per sex per dose:
6

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes


DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily

BODY WEIGHT: Yes

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY: 3 of the 6 animals died after the 7th application and further applications were discontinued. Signs of systemic toxicity appeared 48 hours before death and the surviving animals were below normal in appearance.

BODY WEIGHT AND WEIGHT GAIN: None of the animals gained weight and the weight of those that died decreased significantly prior to death.

OTHER FINDINGS:
Irritation scores (according to Draize, 1955) at 1, 2, 3, 4, 5, 6 and 7 day is as follows:
Animal 1:  Erythema 0, 1, 0, 1, 2, 2, 2 Edema 0, 0, 0, 0, 0, 1, 2
Animal 2:  Erythema 1, 1, 3, 3, 3, 3, 3 Edema 0, 0, 1, 1, 0, 0, 1
Animal 3:  Erythema 0, 0, 0, 1, 2, 3, 3 Edema 0, 0, 0, 0, 2, 2, 1
Animal 4: Erythema 0, 0, 1, 1, 2, 2, 2 Edema 0, 0, 0, 0, 0, 0, 0
Animal 5: Erythema 0, 0, 0, 3, 3, 4, 4 Edema 0, 0, 0, 1, 1, 2, 2
Animal 6: Erythema 0, 0, 0, 1, 1, 3, 3 Edema 0, 0, 0, 0, 0, 0, 0
Reversibility: Not indicated

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion