Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-12-10 -
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to the OECD Guideline 437 and therefore considered reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
yes
Remarks:
The measurement of the opacity was performed with a photometer (570 nm) in-stead of an opacitometer. This can be seen as uncritical, because the opacity can be calculated from the absorption
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Name Acetamid
Appearance colorless crystal substance
CAS No. 60-35-5
EINECS-No. 200-473-5
Molecular formula C2H5NO
Molecular weight 59.07 g/mol
Purity content > 99 %

Test animals / tissue source

Species:
other: not applicable, in vitro
Strain:
other: not applicable, in vitro
Details on test animals or tissues and environmental conditions:
not applicable, in vitro

Test system

Vehicle:
other: suspension with a concentration of 20 % in 0.9 % sodium chloride solution
Controls:
other: not applicable, in vitro
Amount / concentration applied:
750 µL of the test item were tested as suspension at 20% concentration in 0.9% sodium chloride solution.
Duration of treatment / exposure:
Exposition time on the corneas was 4 h ± 5 min.
Observation period (in vivo):
330 min
Number of animals or in vitro replicates:
not applicable, in vitro

Results and discussion

In vivo

Results
Irritation parameter:
other: In Vitro Irritancy Score
Basis:
mean
Time point:
other: 4 hours
Score:
> 55
Max. score:
0.951
Reversibility:
not specified

Any other information on results incl. tables

Absorbance and Opacity Values Negative Control

Parameter

Negative Control

Absorbance before exposition

0.1690

0.1633

0.1622

Absorbance after exposition

0.2277

0.2201

0.2861

Opacity before exposition

1.4757

1.4565

1.4528

Opacity after exposition

1.6893

1.6600

1.9324

Opacity Difference

0.2136

0.2035

0.4796

Absorbance and Opacity Values Test Item and Positive Control

Parameter

Test ItemAcetamid 

Positive Control

Absorbance before exposition

0.2165

0.1200

0.1957

0.1634

0.2081

0.1341

Absorbance after exposition

0.2603

0.4343

0.4815

1.8171

1.8312

1.7969

Opacity before exposition

1.6463

1.3183

1.5693

1.4568

1.6147

1.3618

Opacity
after exposition

1.8210

2.7183

3.0304

65.6296

67.7954

62.6470

Opacity
Difference

0.1747

1.4001

1.4611

64.1728

66.1806

61.2852

IVIS

Test Group

IVIS

Mean IVIS

Relative Standard Deviation IVIS

Negative Control
0.9% NaCl

0.791

0.679

27.2 %

0.466

0.780

Test Item
Acetamid

- 0.129

0.951

103.6 %

1.802

1.180

Positive Control
Imidazole 20%

74.8

77.4

2.9 %

78.3

79.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item Acetamid showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.951. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
Executive summary:

The eye irritative properties of Acetamide were evaluated in the BCOP Test following OECD Guideline 437 resp. EU Method B.47. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.

The test itemAcetamidwas brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for4 hours at32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.

Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.

20 % imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea.

The test itemAcetamidshowed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.951.

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