[2-(2-methoxymethylethoxy)methylethoxy]propanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to EPA/OPP guideline and in accordance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[2-(2-methoxymethylethoxy)methylethoxy]propanol

EC Number:

247-045-4

EC Name:

[2-(2-methoxymethylethoxy)methylethoxy]propanol

Cas Number:

25498-49-1

Molecular formula:

C10H22O4

IUPAC Name:

[2-(2-Methoxymethylethoxy)methylethoxy]propanol

Details on test material:

- Name of test material (as cited in study report): A273956
- Physical state: Liquid
- pH: 6.0
- Storage condition of test material: Ambient laboratory conditions

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Clerco Research Farm, Cincinnati, OH.
- Age at study initiation: Young adult
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature: 67±5 Deg. F
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): One-tenth (0.1) millitier/eye

Duration of treatment / exposure:

0.1 ml of material was placed in the right eye .
The treated eyes of 6 rabbits were unwashed.
The treated eyes of 3 rabbits were washed for 1 minute with lukewarm tap water at a rate of approximately 1 liter per minute beginning approximately 30 seconds after installation of the test article.

Observation period (in vivo):

1, 24, and 48 hours and 72 hours.

Number of animals or in vitro replicates:

Unwashed eye group-6 animals
Washed eye group- 3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : The treated eyes of 3 rabbits were washed for 1 minute with lukewarm tap water at a rate of approximately 1 liter per minute beginning approximately 30 seconds after installation of the test article.

- Time after start of exposure: The right eye of each animal was examined for ocular irritation and lesions at 1 hour
(± 15 minutes), and at 24, 48, and 72 hours (± 2 hours at each interval).


SCORING SYSTEM: Draize Score

TOOL USED TO ASSESS SCORE: A pocket flashlight without magnification was used at all evaluation intervals, and a 2% sodium fluorescein solution in deionized water was used at all evaluations except for those done at 1 hour after instillation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Remarks on result:

other: unwashed eye group

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Remarks on result:

other: washed eye group

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Remarks on result:

other: unwashed eye group

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Remarks on result:

other: washed eye group

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unwashed eye group

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: washed eye group

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.6

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: unwashed eye group

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: washed eye group

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the annex VI of the council directive 67/548 EEC (amended by directive 83/467 EEC) the average scores over all animals for cornea opacity, iris lesions, conjunctivae and chemosis were 0, 0, 0.4 and 0.6, respectively at 24, 48 and 72 hours. According to EEC criteria no classification for eye irritancy is required.

Executive summary:

The test article, A273956, was evaluated for primary eye irritation after instillation in the right eyes of 9 rabbits.

This study was designed to comply with the procedure described in EPA/OPP Guidelines, 1982.

The eyes of 3 of these 9 rabbits were washed with lukewarm tap water after instillation. The treated eyes of all animals (washed and Unwashed) were evaluated at 1, 24, 48, and 72 hours after installation.

No mortalities or abnormal clinical signs were observed during the study. Blistering of the conjunctivae was noted for all the unwashed and washed group animals at the one hour evaluation, which was fully reversible before 72 hours.