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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to: INVITTOX Protocol No. 47: HET-CAM Test.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: INVITTOX Protocol No. 47: HET-CAM Test. http://ecvam-sis.jrc.it
GLP compliance:
yes (incl. QA statement)

Test material

Test animals / tissue source

Species:
other: HET-CAM
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Approx. 100 mg of the neat test item were applied onto the CAM
Duration of treatment / exposure:
5 min
Details on study design:
Approx. 100 mg of the neat test item were applied onto the CAM in order to cover at least 50% of the CAM. The CAM was exposed to the test item for 5 minutes. During this 5 minutes reactions on the blood vessels in and under the CAM in close proximity to the test item were monitored. The CAMs of three eggs were treated with the test item. In addition to the test item a negative control (0.9% NaCl w/v)), two positive controls (1% SDS solution in deionised water and 0.1 N NaOH), and a reference item (5% (w/v) Texapon) were tested.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean (5 min. exposure)
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Table 1: Results with SAT 090073, as well as negative and positive controls, and the reference item


Test Group

Time until Haemorrhage [s]

Time until Lysis [s]

Time until Coagulation [s]

Irritancy Index

Mean Irritancy Index

Negative Control

301

301

301

0.00

0.00

301

301

301

0.00

301

301

301

0.00

Positive Control

0.1 N NaOH

10

45

17

19.34

19.26

9

41

16

19.48

11

57

20

18.96

Positive Control

1% SDS

13

30

301

11.12

11.11

14

28

301

11.15

14

32

301

11.06

Reference Item 5% AS Texpon

17

35

301

10.94

10.78

22

47

301

10.58

20

38

301

10.82

Test Item

301

301

301

0.00

0.00

301

301

301

0.00

301

301

301

0.00

Mean irritancy index of 3 eggs: Test Item = 0.00

Mean irritancy index of 3 eggs: Positive Control (Sodium dodecyl sulphate) = 11.11

                                                        Positive Control (Sodium hydroxide solution) = 19.26

                                                        Reference Item (Texapon) = 10.78

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
other: INVITTOX Protocol No. 47: HET-CAM Test. http://ecvam-sis.jrc.it
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item SAT 090073 does not possess any irritating potential.
Executive summary:

This in vitro study was performed to assess the irritating potential of SAT 090073 by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs.

Each 300 µL of the test item, the positive and the negative controls, and the reference item were applied to three eggs each such that at least 50 % of the membrane was covered. During the observation period for 300 seconds any lesions in close proximity to the covered membrane were monitored and recorded. The observation time was 5 minutes at room temperature.

Physiological sodium chloride solution (0.9 % (w/v) in deionised water) was used as negative control.

The negative control showed no irritating effect on the blood vessels under the membrane. The irritancy mean index is 0.00.

A 1 % solution of SDS and 0.1 NaOH were used as positive controls.

The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 11.11 for 1 % SDS and 19.26 for 0.1 N NaOH. The reference itemTexapon ASV Spezial (5 % AS) was chosen because of its known eye irritating properties and induced a severe irritation on the blood vessels. The calculated mean irritancy index is 10.78.

The mean irritancy indices of the controls are well comparable with the historical control values and are within the acceptance criteria. The result of the reference item demonstrated a correct interpretation. Therefore, it was concluded that the test was valid.

No irritating effects were observed during 5 min incubation with SAT 090073. The calculated irritancy mean index is 0.00.