Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: In alternative Methods in Toxicology, Vol. 6, progress in-Vitro Toxicology, pp.131-138
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
source: air products and chemicals, INC
date received: 01/08/92
test article label: selectflour(TM) Flourination Reagent, RD-591-11874-88
Storage: The test article was stored at ambient room temperature & humidity.
Test Article description: White Powder
sample preparation: the test article was diluted with distilled water to appropriate concentrations.

Test animals / tissue source

Species:
other: fertile DeKalb XL strain eggs
Details on test animals or tissues and environmental conditions:
Forty fertile DeKalb XL strain eggs was selected for use from a larger group received on 01/03/92 from Moyer's Chicks, quakertown, pennsylvania. the eggs were kept in incubators at 99±2℉ and 50-60% relative humidity and their position within the incubator changed daily.

Test system

Amount / concentration applied:
There're four groups.
Group No. 1: 0.05%
Group No. 2: 0.10%
Group No. 3: 0.50%.
Group No. 4: 1.00%.
Number of animals or in vitro replicates:
every group has 10 eggs.
Details on study design:
Upon received the eggs were placed in a commercial incubator for 14 days. During this 14 day period, the positioning of the eggs trays within the incubator was rotated daily, Monday through Friday, to ensure even atmospheric exposure.

On day 4 of the incubation period, the eggs were removed from the incubator and candled to determine the location of the embryo. After determining the presence and location of the embryo, a small hole was drilled into the narrow end of each egg and approximately 2.5ml of albumen was removed using a needle and syringe. The hole was then sealed with collodion adhesive. A rectangular window was then cut in through the shell directly over the developing embryo. All cutting was performed using a dentist’s drill with a diamond wheel bit. The rectangular window was removed with forceps and the opening covered with transparent tape and the egg returned to the incubator.

On day 14 the eggs were removed from the incubator, the tape peeled back and the chorioallantoic membrane(CAM) examined for any abnormalities. Any egg with improperly developed membranes, undeveloped membranes or any abnormality was discarded.

Following the pre-dose examination, a Teflon ring was gently placed on the CAM and 40 ul of the test article dilution was pipette into the ring. The window was then re-sealed, the egg numbered and then returned to incubator.

Results and discussion

Any other information on results incl. tables

Group No.1

Concentrations: 0.05%

Egg number

Observations

91

92

93

94

95

96

97

98

99

100

Normal

x

x

 

x

x

x

x

x

x

 

Ghost vessels

 

 

x

 

 

 

 

 

 

x

 

 

Group No.2

Concentrations: 0.10%

Egg number

Observations

31

32

33

34

35

36

37

38

39

40

Normal

x

x

 

 

 

x

x

x

 

x

Ghost vessels

 

 

x

x

x

 

 

 

x

 

 

 

Group No.3

Concentrations: 0.50%

Egg number

Observations

11

12

13

14

15

16

17

18

19

20

Normal

 

 

 

 

 

x

x

 

 

x

Ghost vessels

x

x

x

x

x

 

 

x

x

 

 

 

 

Group No.4

Concentrations: 1.00%

Egg number

Observations

81

82

83

84

85

86

87

88

89

90

Normal

 

 

 

 

 

 

x

 

 

 

Capillary injection

 

 

 

 

 

x

 

 

 

 

Ghost vessels

x

x

x

x

x

x

 

x

x

x

Minimal hemorrhage

 

x

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
other: Causes serious eye damage.
Executive summary:

The RC50and 95% confidence Limited are: 0.18( 0.08-0.40)%. Based on the results of this study, the test article is an eye irritant.