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EC number: 480-880-4 | CAS number: 608-23-1
- 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
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Endpoint summary
Administrative data
Description of key information
3-Chloro-o-xylene was a skin sensitiser in a Kligman Maximisation Test according to OECD 406.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 25 Nov 2003 to 20 Dec 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Reliable maximisation test
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Inc., Chelmsford, MA, USA
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: at least 21 days
- Weight at study initiation: 272.1 - 486.9 g
- Housing: in groups
- Diet: TEK Hi-Fiber Guinea Pig Diet 2041, Harlan Teklad, Madison, WI, USA, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 50 %
- Day(s)/duration:
- single exposure
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- Day 7
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- other: highest concentration technically achievable
- No. of animals per dose:
- 10 of each sex (test substance), 5 of each sex (negative control), 2 males and 3 females (positive control)
- Details on study design:
- RANGE FINDING TESTS: primary irritation study with 100%, 50%, 10%, and 1% diluted in cottonseed oil (CSO) for intradermal exposure and 100%, 75%, 50% and 25% in CSO for topical application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and topical)
- Exposure period: 48 h
- Test groups: Injection pair 1: 0.1 mL FCA 1:1 with CSO; Injection pair 2: 0.1 mL test substance; Injection pair 3: 0.1 mL test substance 1:1 with FCA: topical: pure test substance, occlusive covering
- Control group: Injection pair 1: 0.1 mL FCA 1:1 CSO; Injection pair 2: 0.1 mL CSO; Injection pair 3: 0.1 mL of 50% formulation of vehicle, 1:1 with FCA
- Site: Three pairs of intradermal injections were made so that on each side of the midline there was one row of three injections each. Injection pairs 1 and 2 were given in close proximity to each other cranially, whereas injection pair 3 was located caudally. The injection sites (6) were just within the boundaries of 2 x 4 cm; Topical: The test substance was spread over a 2 x 4 cm piece of filter paper to saturation or in a thick even layer. The patch was covered by an impermeable sheet and secured with a non-adhesive bandage, which was wound around the torso of the animal The dressing was left in place for 48 hours.
- Frequency of applications: twice
- Duration: 7 days
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: up to observation
- Test groups: Pieces of filter paper measuring 2 x 2 cm were secured to the flanks for 24 hours, with the same occlusive bandage as for topical induction, for the test and negative control animals: (1) on the left side, a patch was saturated with the test substance in the highest non-irritant concentration and (2) on the right side, a patch with the vehicle alone. In the positive control animals, the patch on the left side was saturated with 0.1% Benzocaine in ethanol instead of the test substance.
- Control group: see above
- Site: flanks
- Concentration: 100 %
- Evaluation (hr after challenge): 3 and 24 h - Positive control substance(s):
- yes
- Remarks:
- 0.1 % benzocaine in ethanol
- Positive control results:
- 100 % erythema, extremely sensitising
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- 16/20 the test animals (80% sensitisation) exhibited discrete to moderate erythema at the challenge exposure.Eight of the sixteen were still exhibiting signs of erythema at 48 hours after challenge. No systemic signs of toxicity were observed.
- Remarks on result:
- other: results at 3 and 24 h after challenge are combined
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: results at 3 and 24 h after challenge are combined
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- The positive control animals exhibited skin reactions at each observation point
- Remarks on result:
- other: results at 3 and 24 h after challenge are combined
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test substance was strongly sensitising.
- Executive summary:
1-Chloro-2,3-dimethylbenzene was tested in a skin sensitisation Kligman Maximisation Test (OECD 406) with guinea pigs. Based on a pretest, intradermal induction was performed with 50 % test item in cottonseed oil, topical induction with 100 %. The test item produced discrete to moderate erythema after challenge in sixteen out of twenty of the test animals (80 % sensitisation), and was therefore considered to be a strong sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
1-Chloro-2,3-dimethylbenzene was tested in a skin sensitisation Kligman Maximisation Test (OECD 406) with guinea pigs. Based on a pretest, intradermal induction was performed with 50 % test item in cottonseed oil, topical induction with 100 %. The test item produced discrete to moderate erythema after challenge in sixteen out of twenty of the test animals (80 % sensitisation), and was therefore considered to be a strong sensitizer. As intradermal induction was performed with > 1% (50 %) test item, and resulted in a response > 60 % (80 %) a classification in Cat 1 B is required according to Regulation (EC) No 1272/2008, 3.4.2.2.3.3.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Due to the positive findings in a reliable in vivo skin sensitisation test a classification for sensitisation (1B) is required according to the criteria of Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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