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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable with restrictions (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:
According to the method of Draize JH (Food Drug & Cosmetics Law J. 10: 722-732, 1955).
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Simonson laboratory in Gilroy, California
- Weight at study initiation: 2-2.5 kg
- Diet (e.g. ad libitum): standards rabbit pellets

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
eyes were kept unwashed
Observation period (in vivo):
48 h
Number of animals or in vitro replicates:
3
Details on study design:
- Normal rabbit eyes were preselected on the basis of absence of grossly visible staining by a 5% aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after instillation. After a two hours interval, to allow the eyes to return to normal, a compound was instilled into one eye. The compound was dropped on the center of the cornea while the lids were retracted, about one minute later the lids were released.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize (1955). Individual scores for each irritation parameters were not observed, a total score was determined. Grading of scores was as follows:
0-30 = mild
31-60 = moderate
60 = severe

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: Average of 1, 24 and 48 h readings
Score:
72
Reversibility:
not specified
Irritant / corrosive response data:
Despite the severity of the primary injury there was no blindness or adverse effects on the cornea, lens or iris observed.

Any other information on results incl. tables

Animal No.

Score at (h)

High score

 

Average score

1

24

48

1-48 h

24-48 h

1

56

62

80

 

96

66

71

2

56

80

86

74

83

3

96

70

63

76

67.5

 Total Mean

72

73.5

Applicant's summary and conclusion