[2-(1-ethoxyethoxy)ethyl]benzene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

No examination was done 1 hour after instillation, observation for 7 days.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

1

Reference substance name:

[2-(1-ethoxyethoxy)ethyl]benzene

EC Number:

219-868-9

EC Name:

[2-(1-ethoxyethoxy)ethyl]benzene

Cas Number:

2556-10-7

Molecular formula:

C12H18O2

IUPAC Name:

[2-(1-ethoxyethoxy)ethyl]benzene

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: caged individually
- Other: the animals receive no hay or other extraneous material that might enter the eyes

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL testing material

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize and Kelley (1952)
The eyes of the animals were examined before testing and only those animals without observable eye defects were used.
The test material is allowed to fall on the everted lower lid of one eye of each rabbit and the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent loss of material.
The eyes were not washed following the installation and the animals were released immediately.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2 and 4

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

chemosis score

Basis:

animal: 2 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight redness of the conjunctivae in four out of six rabbits and slight swelling of the conjunctivae in one out of six rabbits were noted. After seven days all lesions cleared up.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

Based on EU CLP criteria (EC 1272/2008 and its updates)

Conclusions:

Under the conditions of this test (simialr to OECD TG 405), Hyacinth body is not considered to be an eye irritant.

Executive summary:

The eye irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD 405 but with (acceptable) deviations on the observation period and therefore a Klimisch 2 rating was assigned. In this study, 6 New Zealand white rabbits were used. Prior to instillation, eyes of the animals were examined for visible eye defects. 0.1 mL of testing material per animal was instilled in one eye and the other eye served as control. Eyes were not washed after instillation. Animals were observed at 24, 48, 72 and 7 days after instillation. No cornea and iris effects were noted. Slight redness of the conjunctivae in four out of six rabbits was seen (score 1 in 1 animal and score 0.66 in 3 animals; out of max. score 3), as well as a slight swelling of the conjunctivae in one out of six rabbits was noted (score 0.33 out of max. score 4). After seven days all lesions had cleared up. Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.