Acetamide

Eye irritation

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

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. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acetamide

EC Number:

200-473-5

EC Name:

Acetamide

Cas Number:

60-35-5

Molecular formula:

C2H5NO

IUPAC Name:

acetamide

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.