Xylene

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Regulatory review

Type of information:

experimental study

Adequacy of study:

key study

Study period:

N/A

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Scientific position underpinning EU occupational exposure limit for xylene isomers

Justification for type of information:

N/A

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1992

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

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

Test material information

Constituent 1

Reference substance name:

o-xylene

EC Number:

202-422-2

EC Name:

o-xylene

Cas Number:

95-47-6

Molecular formula:

C8H10

IUPAC Name:

o-xylene

Constituent 2

Reference substance name:

m-xylene

EC Number:

203-576-3

EC Name:

m-xylene

Cas Number:

108-38-3

Molecular formula:

C8H10

IUPAC Name:

m-xylene

Constituent 3

Reference substance name:

p-xylene

EC Number:

203-396-5

EC Name:

p-xylene

Cas Number:

106-42-3

Molecular formula:

C8H10

IUPAC Name:

p-xylene

Specific details on test material used for the study:

N/A

Test animals / tissue source

Species:

other: human

Strain:

other: N/A

Details on test animals or tissues and environmental conditions:

N/A

Test system

Vehicle:

other: N/A

Controls:

other: N/A

Amount / concentration applied:

N/A

Duration of treatment / exposure:

N/A

Observation period (in vivo):

N/A

Duration of post- treatment incubation (in vitro):

N/A

Number of animals or in vitro replicates:

N/A

Details on study design:

N/A

Results and discussion

In vitro

Other effects / acceptance of results:

N/A

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/m^3

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/m^3). 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/m^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/m^3). A STEL of 100 ppm (442 mg/m^3) was recommended to limit peak exposures which could result in eye and respiratory tract irritation.

Other effects:

N/A

Any other information on results incl. tables

N/A

Applicant's summary and conclusion

Interpretation of results:

other: N/A

Conclusions:

N/A

Executive summary:

N/A