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EC number: 217-210-5 | CAS number: 1777-82-8
- 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:
- key study
- Study period:
- 1981-05-11 to not provided
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted equivalent to a guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- please refer to "Principles of method"
- Principles of method if other than guideline:
- The guinea pig maximization test was conducted according to Magnusson, B. and Kligman, A.M. (eds.): Identification of Contact Allergens in Allergic Contact Dermatitis in the Guinea Pig, C.C. Thomas, Illinois, USA; pp. 102-123. This test method was later included into the OECD Guideline 406.
Deviations from the protocol in the report were:
- The protocol states the room will be air-conditioned with the air temperature maintained at 18 °C +/- 3 °C and relative humidity of 60 % (+ 10 %). Temperature range recorded during the study was 16- 22°C. Humidity range recorded during the study was 52- 81 % (air-conditioning unit not functioning correctly).
- Protocol states main tap water containing 0.1 % ascorbic acid will be freely available. During the study tap water containing 0.01 % ascorbic acid was freely available (Error in original protocol, 0.01% is the level of ascorbic acid for this type of study).
- Protocol specifies the use of Whatmans Number 1 filter paper in topical applications. Whatman Number 3 paper was used throughout the study (Whatman Number 1 paper was not available).
- Protocol specifies the challenge application is carried out at a single concentration of the test material. The challenge was conducted using two concentrations of test material (Standard Toxicol Laboratories Procedure, carried out in error for this study). - GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Information from in vivo test other than LLNA was already available before LLNA guideline was in place.
Test material
- Reference substance name:
- 2,4-dichlorobenzyl alcohol
- EC Number:
- 217-210-5
- EC Name:
- 2,4-dichlorobenzyl alcohol
- Cas Number:
- 1777-82-8
- Molecular formula:
- C7H6Cl2O
- IUPAC Name:
- (2,4-dichlorophenyl)methanol
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
- Source: accredited breeder
- Age at study initiation:
- Weight at study initiation: 300-400 g
- Housing: groups of max.. 5 animals
- Diet: ad libitum, TR2 with added vitamin C manufactured and supplied by Pilsbury's Birmingham,
- Water: ad libitum, containing 0.01 % vitamin C
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 52-81
- Photoperiod (hrs dark / hrs light): 10/14
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction Phase: Injection, 50 % concentration of the test material in ethanol, with and without FCA
Induction Phase: Topical Application, 50 % concentration of the test material in ethanol
Challenge Phase: 50 % and 25 % concentrations of the test material in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction Phase: Injection, 50 % concentration of the test material in ethanol, with and without FCA
Induction Phase: Topical Application, 50 % concentration of the test material in ethanol
Challenge Phase: 50 % and 25 % concentrations of the test material in ethanol
- No. of animals per dose:
- 20 test animals and 8 control animals, and 4 animals for the dose finding test
- Details on study design:
- RANGE FINDING TESTS: Performed in 4 animals pretreated with FCA. Concentrations of 50, 25, 12.5, 6.25 % were used in topical application (occlusive) for 24 h. After 24 h and 48 h sites were scored and maximum non-irritant concentration was selected.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 injection, 1 topical application)
- Exposure period: : Injection, 7 days later 48 h exposure to topical application
- Control group: vehicle control group (ethanol) with the same form of applications
- Site: shoulder region, 4*2 cm area
- Frequency of applications: 2 times (1 injection, 1 topical application)
- Duration: 48 h for topical application
- Concentrations: 50 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 14 days after topical induction
- Exposure period: 24 h
- Site: flanks of the animals
- Concentrations: 50 % on one flank, 25 % on the other flank
- Evaluation (hr after challenge): 24 and 48 h after removal - Challenge controls:
- One vehicle control group was done.
- Positive control substance(s):
- no
Results and discussion
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:
- 19
- Clinical observations:
- 1 animal died during the study
- 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: 19.0. Clinical observations: 1 animal died during the study.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- 1 animal died during the study
- 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: 19.0. Clinical observations: 1 animal died during the study.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- 1 animal died during the study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: 1 animal died during the study.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- 1 animal died during the study
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: 1 animal died during the study.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 8
- 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: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 8
- 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: 8.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 8.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 8.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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