(2-methoxymethylethoxy)propanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study with human volunteers published in the peer reviewed literature. Sufficient data is available for interpretation of results in the publication.

Data source

Reference

Reference Type:

publication

Title:

Local Ophthalmic Effects of Dipropylene Glycol Monomethyl Ether

Author:

Balantyne, B.

Year:

1984

Bibliographic source:

J. Toxicol. Cutan. Ocul. Toxicol. 2: 229-242.

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: human volunteer study

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(2-methoxymethylethoxy)propanol

EC Number:

252-104-2

EC Name:

(2-methoxymethylethoxy)propanol

Cas Number:

34590-94-8

Molecular formula:

C7H16O3

IUPAC Name:

2-[(1-methoxypropan-2-yl)oxy]propan-1-ol

Details on test material:

- Name of test material (as cited in study report): Dipropylene glycol monomethyl ether
- Physical state: Colorless liquid

Test animals / tissue source

Species:

human

Test system

Vehicle:

water

Controls:

no

Amount / concentration applied:

A droplet, 0.04 ml in volume, of 20% (v/v) aqueous DPGME was applied to the left eye using a micrometer syringe euipped with a soft polythene delivery tube.

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

Measurements were made a few minutes before applying DPGME to the eye, and at 2-4, 30 and 60 min after contaminating the eye.

Number of animals or in vitro replicates:

10 human male volunteers

Results and discussion

In vivo

Results

Irritation parameter:

other: sensory irritation in human eyes

Basis:

other: data from 10 human volunteers

Time point:

other: 1 min to 2 hours after exposure

Score:

0

Reversibility:

fully reversible within: 2 hours

Remarks on result:

other: mild transient sensory irriation

Irritant / corrosive response data:

Application of a 0.04 ml of a 20% aqueous solution to human eyes produced  mild transient sensory irritation, hyperemia of conjunctival vessels and  a small increase in intraocular pressure.  All effects disappeared within  2 hr.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test material was classified as not irritating to the eye based on this study with 10 human volunteers.

Executive summary:

10 informed male volunteers of age range 18 -26 yr, were used in the study in order to obtain effects of controlled applications of DPGME solutions to the human eye. A droplet, 0.04 ml in volume, of 20% (v/v) aqueous DPGME was applied to the left eye using a micrometer syringe equipped with a soft polythene delivery tube. Measurements were made a few minutes before applying DPGME to the eye, and at 2-4, 30 and 60 min after contaminating the eye. Application of a 0.04 ml of a 20% aqueous solution to human eyes produced  mild transient sensory irritation, hyperemia of conjunctival

 vessels and a small increase in intraocular pressure. All effects disappeared within 2 hr. The test material was classified as not irritating to the eye.