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Toxicological information

Eye irritation

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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

Reference
Name:
Unnamed
Type:
Constituent
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.