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EC number: 203-396-5
CAS number: 106-42-3
The available data indicate that mixed xylene and the individual isomers (m-, o- and p-xylene) should be considered to be irritating to skin, eyes and the respiratory tract.
skin corrosion potential was determined by exposing the intact skin of
six rabbits to p-xylene for four hours. The sites of application were
not destroyed or changed irreversibly during or after the exposure.
CHEVRON PARAXYLENE 99% was considered not to be corrosive to the intact
skin of rabbits.
Eye Irritation Score Ranges and Means with
Means based on six observations.
redness (vessels definitely injected above normal to more diffuse,
deeper crimson red, individual vessels not easily discernible) was noted
in all 6 rabbits at 1 h post instillation of o-xylene. Conjunctival
chemosis (swelling above normal) and conjunctival discharge (any amount
above normal) were noted in 5 rabbits at 1 h post instillation.
Phonation at instillation was noted in 4 rabbits. No corneal opacity or
iritis was noted in any of the 6 rabbits. All ocular lesions had cleared
by Day 7.
irritation/corrosion of mixed xylene and the xylene isomers was reviewed
and reported in the ATSDR (2007). Some additional relevant data from
proprietary studies has been sourced.
skin irritation was noted in rats and rabbits treated topically with
mixed xylenes or the xylene isomers although by exception, Smyth (1962)
found m-xylene to be non-irritating after non-occluded application to
rabbit skin. The
extent of the irritation appeared to increase with duration of exposure;
the most severe dermal irritation ratings were obtained in the longest
exposures of 10-days (Hine, 1970).
effects of short-term occlusive and repeated non-occlusive dermal
exposure to m-xylene was investigated in the hairless rat using
erythema, transepidermal water loss and skin moisture content as
indicators of dermal irritation (Chatterjee, 2005). M-xylene was found
to be mildly irritating to skin following single occluded exposure and
repeated non-occluded contact and to damage the barrier function of the
histological and molecular changes in rodent skin caused by brief
topical occluded exposure to m-xylene were also investigated (Gunasekar,
2003) and epidermal-dermal separation and granulocyte infiltration and
increases in IL-1α and iNOS protein expression were observed.
corrosion potential was determined in one study and this study evaluated
p-xylene (Chevron Chemical Company, 1973). The
intact skin of six rabbits was exposed to p-xylene for four hours. The
sites of application were not destroyed or changed irreversibly during
or after the exposure and p-xylene was considered not to be corrosive to
the intact skin of rabbits.
There is little human
information available but ATSDR (2007) reports that dermal exposure of
humans to xylene causes skin irritation, dryness and scaling of the
skin, and vasodilation.
eye irritation was observed in rabbits treated with mixed xylenes
although Smyth (1962) found m-xylene to be non-irritating. Primary
irritation studies in rabbits using the washed and unwashed eye (HLA,
1983) demonstrated transient eye
irritation (conjunctival redness and oedema) following exposure to
corneal effects were reported
in either study.
irritation of the eye was reported in volunteer studies where
individuals were exposed to 442 mg/m3 mixed xylene for 15-30
minutes (Carpenter et al, 1975; Hastings et al, 1984).
respiratory tract irritancy study in mice (HLA, 1983) reported that
exposure to o-xylene at a nominal concentration of 9480 mg/m3
via air inhalation resulted in very slight to slight depressions in
respiratory rates indicative of very slight to slight respiratory
p-xylene at a nominal concentration of 11580 mg/m3, slight to severe
depressions in respiratory rates indicative of slight to severe
respiratory irritation were reported (HLA, 1983).
irritation study in mice (De Ceaurriz, 1981) reported a decrease in
respiratory rate during a 5 minute period of exposure of mice to the
vapour of o-xylene with an RD50 value of 6370 mg/m3.
irritation of the upper respiratory tract was reported in volunteer
studies where individuals were exposed to 442 mg/m3 mixed
xylene for 15-30 minutes (Carpenter, 1975; Hastings, 1984).
symptoms of nose or throat irritation have been reported in volunteers
exposed to mixed xylenes up to 400 ppm (UK HSC, 2001). Reference
UK HSC (2001): European
Commission Directive 2000/39/EC establishing a First List of Indicative
Occupational Exposure Limit Values at European Community level in
implementation of council directive 98/24/EC on the protection of the
health and safety of workers from the risks related to chemical agents
at work: Consultative Document
Justification for selection of skin
irritation / corrosion endpoint:
Mild-moderate skin irritation was
reported in rats and rabbits treated topically with mixed xylenes or
xylene isomers. The extent of the irritation appeared to increase with
duration of exposure, however the severity of the response did not
appear sufficient to require classification.
Note: Although xylene isomers (including mixed xylenes) are classified
H315 - Skin irritant Cat 2 according to the CLP regulation, the
rationale for this is not clear since the available data indicate a
potential to cause no more than mild-moderate skin irritation.
Justification for selection of eye irritation endpoint:
Xylene isomers (including mixed xylenes) are considered to be
irritating to the eyes and warrant classification H319 - Eye irritant
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: irritating
Effects on respiratory irritation: irritating
Xylene isomers are classified as skin
irritants under CLP (H315 - skin irritant Cat 2). They are considered
to be irritating to the eyes and warrant classification under CLP classification
(H319 - Cat 2):
induces serious eye irritation.
Xylene isomers are considered to be
irritating to the respiratory
system based on the occurrence of reversible irritant effects in animal
studies and should therefore be
classified category 3
(H335) for specific target organ toxicity - single exposure (STOT-SE)
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