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EC number: 429-290-0 | CAS number: 3380-30-1
- 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:
- from 1998-11-16 to 1999-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- , 1996-07-30
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- , adopted on 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 429-290-0
- EC Name:
- -
- Cas Number:
- 3380-30-1
- Molecular formula:
- C12 H8 Cl2 O2
- IUPAC Name:
- 5-chloro-2-(4-chlorophenoxy)phenol
- Details on test material:
- - Name of test material (as cited in study report): FAT 80'220/A
- Physical state: pale beige solid, powder
- Analytical purity: >99 %
- Lot/batch No.: GRU 98
- Expiration date of the lot/batch: 2008-10-31
- Stability under test conditions: test item was stable in PEG 1 % for at least 10 days at room temperature
- Storage condition of test material: in the original container at room temperature (approx. 20°C) away from direct sunlight; the test item was stable under storage conditions.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
- Sex:
- female
- Details on test animals and environmental conditions:
- ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414 Füllins/ Switzerland
- Age at delivery: 4 - 6 weeks
- Body weight at beginning of acclimization period: 306-396 g
- Housing: individually, in Makrolon type 4-cages
- Diet: pelleted standard Natag Ecosan 845 25W4 guinea pig breeding/maintenance diet, ad libitum
- Water: tap water, ad libitum
- Acclimatization period : One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 34-90 %
- Air changes (per hr): 10-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- Induction: 5 % in PEG 400 (intradermal) and 50 % in PEG 400 (epicutaneous)
Challenge: 50 % in PEG 400 (epicutaneous)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- Induction: 5 % in PEG 400 (intradermal) and 50 % in PEG 400 (epicutaneous)
Challenge: 50 % in PEG 400 (epicutaneous)
- No. of animals per dose:
- Control group: 5 females
Test group 10 females - Details on study design:
- RANGE FINDING TEST
A pretest for the identification of a maximally tolerated test item concentration for the induction phase and of the highest non-irritant concentration for the challenge phase in the main study was performed. The Pretest on intradermal application was done on one guinea pig with 1%, 3% and 5% DCPP in PEG 400. The pretest on topical application was conducted on 2 guinea pigs with 10%, 15%, 25% and 50% DCPP in PEG 400.
Intradermal injection of 5% Diclosan caused grade 1 edema/erythema, whereas topical application of 50% DCPP was not irritating.
MAIN STUDY
A. INDUCTION EXPOSURE
The intradermal induction was performed with a 5 % dilution of the test article in PEG 400 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline.
The epidermal induction was conducted under occlusion with the test article at 50 % in PEG 400.
B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the challenge was completed by epidermal application of the test article at 50 % in PEG 400 under occlusive dressing. The animals of the control group were induced with PEG 400 and FCA/physiological saline and challenged similarly to those of the test group.
READING OF CHALLENGE REACTIONS
The challenge site was evaluated 24 and 48 hours after the removal of the patch. The readings were made under artificial fluorescent light (daylight spectrum). Redness constitutes the minimum criterion of an allergic reaction. Strongly sensitized animals display a vivid redness, associated with indurated swelling. The reactions were scored on the basis of the Draize score.
INTERPRETATION
The results obtained from test animals following the challenge applications were compared with the results seen in control animals. An allergic reaction was defined by visible reddening of the challenge site. If the dermal reactions of test animals following the challenge were more marked and/or persistent than those of the control animals, the animals were considered to show evidence of contact hypersensitivity. If the dermal reactions of test animals following the challenge were not clearly different from the reactions seen in the control group animals, the results for the test animals were considered "inconclusive".
The test animals were considered to show no evidence of contact hypersensitivity if the dermal reactions to the challenge application were identical to or less marked and/or persistent than the reactions observed in the control animals. By "maximizing" the exposure and enhancing allergenicity, some problems could arise, particularly in relation to specificity, especially the potential for false-positive reactions. An inflammatory response at challenge may not necessarily be due to allergenicity, but instead may be a false-positive irritant response caused by an inducing hyperirritability. - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- The positive control, 2-mercaptobenzothiazole, elicited a positive response in 10/10 test animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 % induction, 50 % challenge
- 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: negative control. Dose level: 0 % induction, 50 % challenge. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % intradermal and 50 % epicutabeous induction, 50 % challenge
- No. with + reactions:
- 1
- 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: 5 % intradermal and 50 % epicutabeous induction, 50 % challenge. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 % induction, 50 % challenge
- 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: negative control. Dose level: 0 % induction, 50 % challenge. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % intradermal and 50 % epicutabeous induction, 50 % challenge
- No. with + reactions:
- 1
- 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: 5 % intradermal and 50 % epicutabeous induction, 50 % challenge. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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