Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
other: regulatory review
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientific position underpinning EU occupational exposure limit for xylene isomers

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Recommendation from the Scientific Expert Group on Occupational Exposure Limits for Xylenes
Author:
Scientific Expert Group on Occupational Exposure Limits
Year:
1992
Bibliographic source:
SEG/SUM/19B.
Reference Type:
publication
Title:
Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of occupational exposure limit values in implementation of Council Directive 98/24/EC etc etc
Author:
European Commission
Year:
2000
Bibliographic source:
Official Journal of the European Communities L142: 47-50 (16 June 2000)

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Scientific review of underlying human effects data, in support of Dir 2000/39/EC
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
other: human

Results and discussion

In vivo

Results
Irritation parameter:
other: STEL for eye and respiratory tract irritation
Basis:
other: human data
Remarks on result:
other: based on mild eye and respiratory tract effects reported in humans; equivalent to 442 mg/m3
Irritant / corrosive response data:
The critical health effects underpinning the IOELV for xylene isomers were mild irritation of the eye and upper respiratory tract and mild CNS effects noted in some individuals exposed to 100 ppm (442 mg/m3). The findings were considered by the SEG to provide the best available basis for setting an exposure limit for xylene isomers. As the effects seen were minimal, 100 ppm (442 mg/3) was taken as a LOAEL. Application of an uncertainty factor of 2 gave an 8-hr TWA for xylene isomers of 50 ppm (221 mg/m3). A STEL of 100 ppm (442 mg/m3) was recommended to limit peak exposures which could result in eye and respiratory tract irritation.

Applicant's summary and conclusion