2-(1-ethylpentyl)-1,3-dioxolane

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Test performed before current guidelines

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted in September 1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 405, the guideline is not referenced and the study is non-GLP. However, this did not influence the reliability of the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

2-(1-ethylpentyl)-1,3-dioxolane

EC Number:

224-436-8

EC Name:

2-(1-ethylpentyl)-1,3-dioxolane

Cas Number:

4359-47-1

Molecular formula:

C10H20O2

IUPAC Name:

2-(1-ethylpentyl)-1,3-dioxolane

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino strain

Details on test animals or tissues and environmental conditions:

The tests were carried out according to the classical Draize technique.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

Amount applied: 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

STUDY DESIGN
The test material was applied at 100% in 3 animals.

TREATMENT
Similar and in accordance with OECD 405 (1981). The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation:
The eyes of each animal were examined at 1, 24, 48 and 72 hours and 4 and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3 (mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3 (mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, 2

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3 (mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 8

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, 2, 3 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3 (mean)

Time point:

other: 1 hr

Score:

0

Max. score:

0

Results 11

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3 (mean)

Time point:

other: 1 hr

Score:

0

Max. score:

0

Results 12

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, 2, 3

Time point:

other: 1 hr

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hr

Results 13

Irritation parameter:

chemosis score

Basis:

animal: #1, 2

Time point:

other: 1 hr

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 14

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 1 hr

Score:

0

Max. score:

0

Any other information on results incl. tables

Results:

Rabbit no.	Observations	1 hr	24 hr	48 hr	72 hr	7 days
1	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,1,0=4	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0
2	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,1,0=4	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0
3	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

In an eye irritation study with rabbits, performed comparable to OECD 405 (1981), essentially no irritation was observed. Based on the results of this study, the substance is not considered an eye irritant.

Executive summary:

The substance was tested in an eye irritation test in rabbits comparable to OECD 405 (1981). Three New Zealand albino rabbits were used and the substance was used undiluted. The volume applied was 0.1 ml. Ocular effects included only a slight redness of conjunctiva in all 3 animals (score 1) at 1 hr, which were fully reversible within 24 hours in 1 animal and within 48 hours in 2 animals. A slight chemosis was observed in 2 animals (score 1) that was fully resolved within 24 hours. No other effects were seen. Based on the results of this study, the substance is not considered an eye irritant.