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EC number: 204-501-7 | CAS number: 121-86-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-chloro-4-nitrotoluene
- EC Number:
- 204-501-7
- EC Name:
- 2-chloro-4-nitrotoluene
- Cas Number:
- 121-86-8
- Molecular formula:
- C7H6ClNO2
- IUPAC Name:
- 2-chloro-1-methyl-4-nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): 2-Chlor-4-nitrotoluol rein krist.
- Purity: 99.4 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann (Borchen, Germany)
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 295-365 g
- Housing: 5 animals per cage (Makrolon cages type IV) on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- 1st induction (intradermal): 5 %
2nd induction (epicutaneous): 50 %
1st and 2nd challenge (epicutaneous): 50 % and 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- 1st induction (intradermal): 5 %
2nd induction (epicutaneous): 50 %
1st and 2nd challenge (epicutaneous): 50 % and 25 %
- No. of animals per dose:
- 20 (test groups), 10 (control groups)
- Details on study design:
- INTRADERMAL INDUCTION:
Three pairs of intradermal injections were made at the clipped skin site of each animal. A volume of 0.1 ml was injected. Animals of the test group were treated at the following injection sites:
cranial - emulsified Freund's complete adjuvant 1:1 with physiologic saline
medial - 5 % test item in polyethylene glycol 400
caudal - 5 % test item in polyethylene glycol 400 and emulsified Freund's complete aduvant 1:1
Animals of the control group were treated in the same manner excepted that the test item was replaced by the vehicle alone.
TOPICAL INDUCTION:
Treatment group: 0.5 ml of 50 % test item in polyethylene glycol 400; control group: 0.5 ml polyethylene glycol 400
CHALLENGE:
3 weeks after the first induction phase all animals were prepared for challenge by clipping the flanks and backs free of hair. Patches of gauze coated with 0.5 ml aliquots of the test item at 25 or 50 % concentrations were placed alternating cranial or caudal of each animal and fixed with an elastic adhesive bandage. After a contact period of 24 hours patches were removed. The treated sites were examined approximately 48 and 72 hours after patch removal. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 % test substance formulation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Treatment with 2-chloro-4-nitrotoluene was tolerated by all animals without symptoms. No deaths occurred. Body weight development was not affected.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
In a guinea pig maximization test (GPMT) according to OECD TG 406 2-Chlor-4-nitrotoluol rein krist. revealed no skin sensitizing potential at challenge concentrations of 50 and 25 %.
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