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EC number: 287-502-5 | CAS number: 85536-20-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP status not known, non-guideline study, published in peer reviewed literature, limitations in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Petroleum hydrocarbon toxicity studies: V. Animal and human response to vapors of mixed xylenes.
- Author:
- Carpenter CP, Kinkead ER, Geary DJ, et al.
- Year:
- 1 975
- Bibliographic source:
- Toxicol Appl Pharmacol 33:543-558.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- mixed xylenes
- IUPAC Name:
- mixed xylenes
- Reference substance name:
- 33-91
- IUPAC Name:
- 33-91
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- xylene
- Details on test material:
- Mixed xylenes (m- 65.01%, o- 7.63%, p- 7.84% and ethylbenzene 19.27%).
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No details reported
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- no details
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromatography.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 180, 460 or 810 ppm
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
0, 781, 1996 and 3515 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 25 males
- Control animals:
- yes
- Details on study design:
- Groups of 25 male rats were assigned randomly to each of three graded levels of mixed xylenes or to the solvent- free air-control. Three rats from each group were killed for histological examination after 3 and 7 week intervals. Ten rats per group that survived 13 weeks were used for a challenge exposure to determine whether they had become more or less sensitive as a result of the repeated inhalation of vapour. The remaining rats were terminated after 13 weeks (65 days of exposure).
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- Measurements included body weight change and urine and blood analysis. Evaluations on blood included: haematocrit, total erythrocyte count, reticulocyte count, total and differential leucocyte counts, serum alkaline phosphatase (SAP), serum glutamic pyruvic transaminase (SGPT), serum glutamic oxalacetic transaminase (SGOT) and blood urea nitrogen (BUN).
- Sacrifice and pathology:
- At termination, the following tissues were taken for microscopic examination: adrenal, brain, pituitary, trachea, thyroid, parathyroid, lung, heart, liver, kidney, spleen, stomach, duodenum, pancreas, ileum, jejunum, colon, skeletal muscle, sciatic nerve, and bone marrow impression smear. All tissues were examined at each time point for the high dose and control groups, but for the low and intermediate dose only lung, liver, kidney, heart, spleen, adrenal, thyroid, parathyroid, trachea, oesophagus, and bone marrow impression smears were examined.
- Other examinations:
- Groups of ten rats per group that survived exposure over 13 weeks, were subjected to a 4-hr challenge period during which time they inhaled 29.0 mg/L (6700 ppm) of mixed xylenes. Their response was compared to the similarly handled control group and to 20 naive rats that were randomized from the same production lot as those under test but not subjected to daily handling.
- Statistics:
- No details
Results and discussion
Results of examinations
- Details on results:
- Two rats (one control and one low dose) died of extraneous pneumonic infections. All other rats gained weight normally. Minor differences in blood clinical chemistry and haematology were considered not to be adverse effects. Urinalyses performed before rats were sacrificed at 3, 7, and 13 wk revealed no abnormalities. No lesions ascribed to inhalation of mixed xylenes were found at any time point.
No statistically significant differences in median time to death were apparent following the challenge at the end of the study. No protective adaptive mechanism could be claimed as a result of exposure to concentrations as high as 3.5 mg/L (810 ppm) for 6 hr/day x 65 days (5 days /week for 13 weeks.
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- >= 810 ppm
- Sex:
- male
- Basis for effect level:
- other: 3515 mg/m3
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEC of mixed xylenes for male rats exposed 6h/day for 5 days in each of 13 weeks was >=3515 mg/m3.
- Executive summary:
Male rats were exposed 6h/day for 5 days in each of 13 weeks to 0, 0.77, 2.0 or 3.5 mg/L (0, 180, 460 or 810 ppm) mixed xylenes. The NOAEC was >=3515 mg/m3.
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