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Toxicological information

Eye irritation

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
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)
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 5 days

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