Registration Dossier

Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study with human volunteers. No guideline applicable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Study type:
human medical data

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Minimal subjective eye effects were noted at 150 ppm only; there was no impact on objective measures of eye irritation at either exposure level. The NOAEL for eye irritation due to PGME vapor is at least 150 ppm.
Executive summary:

Eye irritation in human volunteers: testing was conducted on 12 healthy male volunteers using a repeated measures design. Each subject was exposed for 2.5 hours to each of three exposure conditions which were spaced 7 days apart. During all exposure sessions, 20 ppm diethylether was used as a masking agent to minimize any responses caused by propylene glycol methyl ether odor. Exposure to the test substance and the effect measurements were conducted in a double-blind fashion. Measurement of pre- and post-exposure eye redness, corneal thickness, tear film break-up time, conjuctival epithelial damage, blinking frequency, and subjective ratings were used to evaluate the possible irritating effects of propylene glycol methyl ether.

Minimal subjective eye effects were noted at 150 ppm only; there was no impact on objective measures of eye irritation at either exposure level. The NOAEL for eye irritation due to PGME vapor is at least 150 ppm.