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EC number: 430-550-0 | CAS number: 1671-49-4
- 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:
- key study
- Study period:
- 4 March - 24 April 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 430-550-0
- EC Name:
- -
- Cas Number:
- 1671-49-4
- Molecular formula:
- C8H9NO4S
- IUPAC Name:
- 4-methanesulfonyl-1-methyl-2-nitrobenzene
- Details on test material:
- - Physical state: white solid
- Storage condition of test material: ambient temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 272-345 g
- Housing: 5 per cage in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet: FD1 ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-23°C
- Humidity: 30-70%
- Air changes: minimum of 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 9 March 1999 To: 24 April 1999 (positive control study 25 January 1999- 19 February 1999)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 3% w/v for intradermal induction, 75% w/v for topical induction, 50% w/v and 25% w/v for challenge applications
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 3% w/v for intradermal induction, 75% w/v for topical induction, 50% w/v and 25% w/v for challenge applications
- No. of animals per dose:
- 20 test and 10 controls
- Details on study design:
- RANGE FINDING TESTS: Groups of 2 or 4 female guinea pigs used and up to 4 dose-levels tested per group to determine dose levels to use for each of the 3 stages of the main study. Intradermal injection: 0.3, 1, 3 and 10% tested. Topical induction: 97 and 75% tested. Challenge: 96, 75, 50 and 25% tested.
MAIN STUDY
A. INDUCTION EXPOSURE - intradermal injection
- Test groups: 3 pairs of injections (0.05-0.1 mL each) of (i) Freund's complete adjuvant (FCA) plus corn oil in ratio 1:1, (ii) 3% w/v preparation of test substance in corn oil, (iii) 3% w/v preparation of test substance in a 1:1 preparation of FCA plus corn oil
- Control group: as for test group except corn oil instead of test substance
- Site: scapular region, row of 3 injections on each side of mid-line
- Frequency of application: single
B. INDUCTION EXPOSURE - topical application (one week after injections)
- Test groups: 200-300 mg of a 75% w/v preparation in corn oil applied on filter paper (approximately 4 cm x 2 cm) under an occlusive dressing for at least 48 hours
- Control group: as for test group except corn oil only applied
- Site: scapular region
- Frequency of application: single
c. CHALLENGE EXPOSURE (two weeks after topical induction)
- Test and control groups: 0.05-0.1 mL of a 50% w/v and a 25 % w/v preparation of the test substance in corn oil were each applied to the shorn flank (50% on left, 25% on right) on a piece of filter paper (approximately 1 cm x 2 cm) under an occlusive dressing for at least 24 hours.
- Evaluation (hr after challenge): 1 and 2 days
OTHER: - Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Following challenge of previously induced guinea pigs with undiluted hexylcinnamaldehyde, the net percentage response was 100%. Hexylcinnamaldehyde was classified as an extreme sensitiser and, therefore, confirmed the validity of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 19
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 19.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 19
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 19.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: negative control (positive control study)
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: negative control (positive control study). Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: negative control (positive control study)
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: negative control (positive control study). Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Table 1: Maximisation test: Number of animals with signs of allergic skin reactions
Scored after: |
24 hours |
48 hours |
|
Test groups |
50% w/v preparation |
17/20 |
5/20 |
|
25% w/v preparation |
1/20 |
0/20 |
Negative/vehicle control |
50% w/v preparation |
4/10 |
3/10 |
|
25% w/v preparation |
0/10 |
0/10 |
Positive control |
19/19 (0/10 control) |
19/19 (0/10 control) |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is considered to be a moderate skin sensitiser.
- Executive summary:
The sensitisation potential of the test substance was assessed using a method based on the maximisation test described by Magnusson and Kligman. The study involved two main procedures: the potential induction of an immune response and a challenge of that response. The sensitisation response was determined 1 and 2 days after challenge by assessing the degree of erythema.
Challenge of previously-induced guinea pigs with a 50% w/v preparation of the test substance in corn oil elicited a moderate sensitisation response and challenge at 25% elicited a weak skin sensitisation response.
A positive control study using hexylcinnamaldehyde demonstrated the sensitivity of the test system.
The substance is considered to be a moderate skin sensitiser.
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