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EC number: 228-782-0 | CAS number: 6358-64-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-11-15 to 2001-02-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP-study according to OECD TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement included in full study report.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The original Test Guideline (TG) for the determination of skin sensitization in the mouse, the Local Lymph Node Assay (LLNA; TG 429)
was adopted in 2002. This study was performed earlier - in 2000.
Test material
- Reference substance name:
- 4-chloro-2,5-dimethoxyaniline
- EC Number:
- 228-782-0
- EC Name:
- 4-chloro-2,5-dimethoxyaniline
- Cas Number:
- 6358-64-1
- Molecular formula:
- C8H10ClNO2
- IUPAC Name:
- 4-chloro-2,5-dimethoxyaniline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Harlan Winkelmann, D-33178 Borchen, SPF breeding colony
- Strain: HsdPoc:DH
- Body weight of the main test group at start of study: Mean = 380g (min: 360g, max: 432g)
- Randomization: Randomization scheme 2000.0453
- Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Room temperature: 20 +/- 3°C
- Rel. humidity: 50 +/- 20 %
- Lighting time: 12 hrs daily
- Acclimatization: at least 7 days
- Diet: ssniff (R) Ms-H (V2233), ad libitum
- Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking with KMnO4 and cage numbering
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: hydroxyethyl-cellulose (Tylose H 4000 G4 PHA)
- Concentration / amount:
- Intradermal induction treatment: 5% test substance in 0.5% aqueous solution of vehicle and 5% test substance in 50% Freund's Adjuvant
Dermal induction treatment: 25% test substance in 0.5% aqueous solution of vehicle
Dermal challenge treatment: 25% test substance in 0.5% aqueous solution of vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: hydroxyethyl-cellulose (Tylose H 4000 G4 PHA)
- Concentration / amount:
- Intradermal induction treatment: 5% test substance in 0.5% aqueous solution of vehicle and 5% test substance in 50% Freund's Adjuvant
Dermal induction treatment: 25% test substance in 0.5% aqueous solution of vehicle
Dermal challenge treatment: 25% test substance in 0.5% aqueous solution of vehicle
- No. of animals per dose:
- Determination of the tolerance of the intradermal injections: 2
Determination of the primary non-irritating concentration: 3
Control group: 5
Treatment group: 10 - Details on study design:
- RANGE FINDING TESTS:
- Determination of the tolerance of the intradermal injections: 2 animals, concentrations tested: 5, 1 and 0.2 % of test substance in 0.5% w/w aqueous solution of vehicle.
- Determination of the primary non-irritating concentration: 3 animals, concentrations tested: 25, 5 and 1 % of test substance in 0.5% w/w aqueous solution of vehicle.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two intradermal injections on day 1, one dermal on day 8
- Exposure period: dermal: between day 2 and day 7: administration areas were examined for local tolerance. Systemic toxic effects were noted, if apparent
- Test groups: 1
- Control group: 1
- Site: dorsal area, in vicinity of shoulders
- Frequency of applications: 1
B. CHALLENGE EXPOSURE
- Dermal challenge treatment start on day 22
- No. of exposures: 1
- Day(s) of challenge: day 22 - day 25 (cahallenge and post-challenge observation)
- Exposure period: 24 hrs, then occlusive bandagae was removed.
- Test groups: 1
- Control group: 1
- Site: left flank
- Evaluation (hr after challenge): 48 and 72 hrs
OTHER: - Positive control substance(s):
- yes
- Remarks:
- The validity of the test system is confirmed periodically by using alpha-hexyl cinnamic aldehyde (Report No 2000.0738, 2000-10-20, Aventis Pharma Deutschland GmbH, ProTox)
Results and discussion
- Positive control results:
- The validity of the test system is confirmed periodically by using alpha-hexyl cinnamic aldehyde (Report No 2000.0738, 2000-10-20, Aventis Pharma Deutschland GmbH, ProTox)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None.
- 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: 10.0. Clinical observations: None..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control group
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Control group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Thus, the percentage of animals reacting positive is below the threshold of 30 %. Based on the results of this study 4-chloro-2,5-dimethoxyaniline showed no evidence for sensitising properties according to the classification criteria of Directive 93/21/EEC. - Executive summary:
Testing for sensitising properties of 4 -chloro-2,5 -dimethoxyaniline was performed in female guinea pigs according to the method of Magnusson & Kligman. Intradermal induction was performed using 5% 4 -chloro-2,5 -dimethoxyaniline in 0.5% w/w aqueous solution of hydroxyethyl-cellulose (Tylose H4000 G4 PHA). Dermal induction and challenge treatment were carried out with 25% 4 -chloro-2,5 -dimethoxyaniline in 0.5% w/w aqueous solution of hydroxyethyl-cellulose (Tylose H4000 G4 PHA).
The validity of the test system is confirmed by periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the Buehler test (report number 2000.0738, dated October 20, 2000; Aventis Pharma Deutschland GmbH, ProTox). Based on the results of this study 4 -chloro-2,5 -dimethoxyaniline showed no evidence for sensitising properties according to the classification criteria of Directive 93/21/EEC.
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