Registration Dossier

Administrative data

Endpoint:
neurotoxicity: inhalation
Remarks:
other: regulatory review
Type of information:
other: Recommendation from the Scientific Committee on Occupational Exposure Limits
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Science position underpinning EU occupational exposure limit for toluene

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2001
Reference Type:
publication
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: human

Administration / exposure

Route of administration:
inhalation: vapour

Results and discussion

Effect levels

Dose descriptor:
other: 8 hr IOELV
Effect level:
50 ppm (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: SCOEL concluded there was a great deal of human data demonstrating no reliable evidence of neurological effects at or below 50 ppm (192 mg/m3), hence 50 ppm was an appropriate level for an 8 hr TWA
Remarks on result:
other:

Applicant's summary and conclusion

Executive summary:

SCOEL noted that toluene exposures in the range 90-150 ppm (345-575 mg/m3) for several hours lead to decrements in neurological test results although some of the findings were difficult to interpret due to uncertainties regarding the relationship between the effects monitored and contemporary / past levels of exposure. However the availability of a great deal of human data indicated no reliable evidence of effects at or below toluene concentrations of 50 ppm (192 mg/m3). SCOEL therefore concluded that 50 ppm (8 hour TWA) was an appropriate level for an IOELV.