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EC number: 935-783-6 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed similar to OECD guideline 406 (GPMT) at a time GLP was not enacted. Minor deviations from OECD guideline 406 occured.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- concentration used for induction was not irritating
- GLP compliance:
- no
- Remarks:
- study was conducted prior to the enactment of GLP principles
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Chlorocresol
- EC Number:
- 200-431-6
- EC Name:
- Chlorocresol
- Cas Number:
- 59-50-7
- Molecular formula:
- C7H7ClO
- IUPAC Name:
- 4-chloro-3-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): Preventol CMK
- Analytical purity: 100%
- Lot/batch No.: 54 603 00
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal, Germany
- Sex: ♂ (1st experiment), ♀ (2nd experiment)
- Weight at study initiation: 400 g (1st experiment); 300 g (2nd experiment)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Lutrol 300/ethanol (3:1)
- Concentration / amount:
- Intradermal induction (Day 0): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle and in Freund's adjuvant, respectively
Topical induction (Day 7): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle
Topical challenge (Day 21):
1st experiment: 25% (right flank), 12.5% CMK (left flank) in vehicle
2nd experiment: 50% (right flank), 25% CMK (left flank) in vehicle
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- other: Lutrol 300/ethanol (3:1)
- Concentration / amount:
- Intradermal induction (Day 0): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle and in Freund's adjuvant, respectively
Topical induction (Day 7): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle
Topical challenge (Day 21):
1st experiment: 25% (right flank), 12.5% CMK (left flank) in vehicle
2nd experiment: 50% (right flank), 25% CMK (left flank) in vehicle
- No. of animals per dose:
- 15
- Details on study design:
- The skin irritating potential of the test substance was assessed in a pre-test with concentrations of 12.5%, 25%, 50% and 100% applied for 24 h under occlusive conditions.
The study followed the Magnusson-Kligman method which is basically compliant with OECD Guideline 406 (GPMT). However, this guideline was not available when the study was conducted.
The study comprised of two experiments each conducted on 15 Pirbright White guinea pigs. In the 1st experiment, male animals received intradermal (in vehicle and in Freund´s adjuvant) and topical induction treatments (in vehicle) with 25% test substance. In the 2nd experiment, females were induced with a 1% test substance via the same procedure. Both experiments included respective vehicle control groups (Lutrol 300/ethanol (3:1) with 15 animals each. The topical induction exposure lasted 48 h. The challenge treatment two weeks after the last induction application was performed with 25% (right flank) or 12.5% (left flank) test item in vehicle in the 1st experiment and with 50% (right flank) or 25% (left flank) test item in vehicle in the 2nd experiment. Each challenge exposure lasted 6 h. Animals of the control groups were challenged in the same way. The Magnusson-Kligman scoring system was used to rate the skin reactions. Scoring of the treated skin was performed 24 and 48 h after challenge. - Challenge controls:
- Yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 0% (12.5+25% challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0% (12.5+25% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (12.5% challenge)
- No. with + reactions:
- 1
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (12.5% challenge). No with. + reactions: 1.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (25% challenge)
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (25% challenge). No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 0% (12.5% challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0% (12.5% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 0% (25% challenge)
- No. with + reactions:
- 1
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0% (25% challenge). No with. + reactions: 1.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (12.5% challenge)
- No. with + reactions:
- 3
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (12.5% challenge). No with. + reactions: 3.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (25% challenge)
- No. with + reactions:
- 13
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (25% challenge). No with. + reactions: 13.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 0% (25 + 50% challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0% (25 + 50% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (25% challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (25% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (50% challenge)
- No. with + reactions:
- 4
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (50% challenge). No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 0% (25 + 50% challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0% (25 + 50% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% (25% challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% (25% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% (50% challenge)
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- No findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% (50% challenge). No with. + reactions: 2.0. Total no. in groups: 15.0. Clinical observations: No findings.
Any other information on results incl. tables
The highest non-irritating concentration after topical dermal application for 24 h was determined as 50%. An short overview of the results is given in the table below.
Table 1: Animals with skin reactions after the challenge phase:
|
Control |
Experiment 1 |
Control |
Experiment 2 |
||||
Induction concentration |
0% |
25% |
0% |
1% |
||||
Challenge concentration |
12.5% |
25% |
12.5% |
25% |
25% |
50% |
25% |
50% |
Time after challenge |
|
|||||||
24 h |
0/15 |
0/15 |
1/15 |
7/15 |
0/15 |
0/15 |
0/15 |
0/15 |
48h |
0/15 |
1/15 |
3/15 |
13/15 |
0/15 |
0/15 |
4/15 |
2/15 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Skin sens 1B, H317
DSD: Xi, R43
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