2-hydroxyethyl acrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Reference 2

Reference Type:

other: company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Principles of method if other than guideline:

BASF test: Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually, 50 uL of the test substance was applied to the conjunctival sac of one eye of 2 animals. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 4 days afterwards. Findings were recorded on working days. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report usually describes findings after 1 and 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data were taken into account (if available).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxyethyl acrylate

EC Number:

212-454-9

EC Name:

2-hydroxyethyl acrylate

Cas Number:

818-61-1

Molecular formula:

C5H8O3

IUPAC Name:

2-hydroxyethyl acrylate

Test material form:

not specified

Details on test material:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2-Hydroxyethyl acrylate
- Physical state: liquid
- Analytical purity: no data
- Impurities: approx. 10 % free acrylic acid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMAL
- Body weight at study initiation: 3.11 kg (mean of 2 rabbits)


ENVIRONMENTAL CONDITIONS
no details given

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent, saline treated eye of same animals served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 50 µL

Duration of treatment / exposure:

once

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2 animals

Details on study design:

Eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 4 days afterwards. Findings were recorded on working days. The eyes were not washed out after 24 hours. The report usually describes findings after 1 and 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

2

Reversibility:

other: no findings during the first 48 hrs

Remarks on result:

other: iritis on day 5 until study termination (score 1)

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks:

no findings during the first 48 hrs

Remarks on result:

other: iritis (score 1) on day 5

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1.5

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Mean scores after 24, and 48 h*:

 

Scores	24 h		48 h		mean
	Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2
Conjunctivae	1	1**	2	3**	1.5	2
Cornea	2	2	3	2	2.5	2
Chemosis	2	2	1	1	1.5	1.5
Iritis	0	0	0	0	0	0
Discharge	smeary overlay	0	smeary overlay	smeary overlay	-	-

*72 hrs-scores were missing in the raw data.

** Nictitating membrane white

 

 

Findings at test termination:

 

Scores	8 d		Additional Findings
	Animal 1	Animal 2	Animal 1	Animal 2
Conjunctivae	1	2	-	Nictitating membrane white
Cornea	2	3	-	staphyloma
Chemosis	0	0	-	-
Iritis	1	0	-	-
Discharge	0	smeary overlay	-	-

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria