[2-(1-propoxyethoxy)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

Justification for type of information:

The eye irritation information of this source substance is used for read across to Hyacinth body #3.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Information derived from analogue

Justification for type of information:

The read across justification is presented in the Irritation / corrosion Endpoint summary. The accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2 and 4

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 5 and 6

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal: 2 to 6

Time point:

24/48/72 h

Score:

0

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 was noted. After seven days all lesions cleared up.

Interpretation of results:

other: not eye irritating

Remarks:

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

Conclusions:

Eye irritation: not irritating (read-across from Hyacinth body tested in OECD TG 405).

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:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize and Kelley (1952)

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

Results 2

Irritation parameter:

iris score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2 and 4

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 5 and 6

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible

Results 7

Irritation parameter:

chemosis score

Basis:

animal: 2 to 6

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Slight redness of the conjunctivae in four out of six rabbits and slight swelling (chemosis) of the conjunctivae in one out of six rabbits was noted. After seven days all lesions had cleared up.

Applicant's summary and conclusion

Interpretation of results:

other: not eye irritating

Remarks:

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

Conclusions:

Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.

Executive summary:

The eye irritation potential of Hyacinth body was tested in vivo using 6 New Zealand white rabbits. A Klimisch 2 rating was assigned as the test was performed similar to OECD 405 but with (acceptable) deviations on the observation period. 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, 47, 72 and 7 days after instillation. No cornea and iris effects were noted. Slight redness of the conjunctivae in four out of six rabbits (with a mean (from 24, 48 and 72 hours) score 0.66 in 3 animals and a mean score 1 in one animal) and slight swelling (chemosis) of the conjunctivae in one out of six rabbits (mean score 0.33) were noted. After seven days all lesions had cleared up. Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.