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EC number: 203-576-3 | CAS number: 108-38-3
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.
The 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 Standard Deviations
Means based on six observations.
Conjunctival 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.
The 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.
Mild-moderate 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).
The 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 skin. 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.
Skin 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.
Moderate 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 o-xylene. No corneal effects were reported in either study.
Mild 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).
A 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 irritation. For 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).
A sensory 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.
Mild 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).
No 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 Cat 2. 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) under CLP.
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