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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:
23.11.17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
2017
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals / tissue source

Species:
cattle
Strain:
other: Bos primigenius Taurus
Details on test animals or tissues and environmental conditions:
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Peni-cillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): #01: 383.4 mg; #02: 386.5 mg; #03: 393.8 mg
- Concentration (if solution):-

VEHICLE
- Amount(s) applied (volume or weight with unit): -
- Concentration (if solution):-
- Lot/batch no. (if required): -
- Purity:-
Duration of treatment / exposure:
Exposure time on the corneas was 4 hours at 32 ± 1 °C.
Number of animals or in vitro replicates:
three replicates per treatment group

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
#01
Value:
0.54
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
#02
Value:
0.34
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
#03
Value:
-0.34
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item 2,2'-Azobis(2,4-dimethylvaleronitrile) showed no effects on the cornea of the bo-vine eye. The calculated IVIS (In Vitro Irritancy Score) is 0.18.
Executive summary:

One valid experiment was performed.

Bovine corneas were used. They were collected from slaughtered cattle, which were between 12 and 60 months old.

The test item2,2'-Azobis(2,4-dimethylvaleronitrile)was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.

The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.

HBSS was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (In VitroIrritancy Score) is 2.51.

20 % imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS (In VitroIrritancy Score) is 120.59.

 

Under the conditions of this study, the test item2,2'-Azobis(2,4-dimethylvaleronitrile)showed no effects on the cornea of the bovine eye. The calculated IVIS (In VitroIrritancy Score) is 0.18.

According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.