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EC number: 202-462-0 | CAS number: 95-88-5
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from review article.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2.5, 5, 10, 25 and 50% in acetone:olive oil (4:1 v/v)
- No. of animals per dose:
- 2.5% -5 nulliparous and non pregnant female mouse
5%- 5 nulliparous and non pregnant female mouse
10% -5 nulliparous and non pregnant female mouse
25% -5 nulliparous and non pregnant female mouse
50% -5 nulliparous and non pregnant female mouse - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Test groups: 3 groups of 5 test animals
- Control group: 5 + 5 (additional study)
- Site: epidermal
- Frequency of applications: 3
- Duration: the experimental animals were epidermally exposed to varying concentrations test chemical on three concesutive days and further testing was done three days after last exposure.
- Concentrations: 5%, 25% and 50% and additionally 2.5% and 10%
OTHER: Three days after the last exposure, all animals were injected with ³H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were done.
Additional study: Based on the results, additional groups were treated at 2.5 and 10%. Five vehicle control animals were similarly treated, but with vehicle alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 2.5, 5, 10 and 25% were 1.1, 1.5, 10.1, 16.4 respectively. An EC3 value of 5.8% was calculated.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Mean DPM/animal values for the experimental groups treated with test substance concentrations 5 and 25 % were 232 and 2473 respectively. The DPM Value for the only surviving animal treated at 50% was 2402. The mean DPM/animal value for the vehicle control group was 151. In order to achieve more information regarding the SI=3 value, additional groups of animals were treated. Mean DPM/animal values for the experimental groups treated with test substance concentrations 2.5 and 10% were 145 and 1351 respectively. The mean DPM/animal value for the vehicle control group was 134.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 4-chlororesorcinol is considered as a strong skin sensitiser, as the EC3-value is found to be less than 10%, when tested as per Mouse local lymphnode assay (LLNA).
- Executive summary:
- Local Lymph Node Assay (LLNA) was performed on
a group of 5 nulliparous and non-pregnant mice to study the skin
sensitizing activity of the test materialA12 / SAT 030626
(4-Chlororesorcinol) at concentrations of 2.5, 5, 10, 25 and 50%.
Vehicle control used was acetone:olive oil (4:1 v/v).
In the main study, three groups of five experimental animals were epidermally exposed to a 5%, 25% and 50% concentration respectively on three consecutive days. Five vehicle control animals were similarly treated, but with vehicle alone (acetone:olive oil (4:1 v/v).
Three days after the last exposure, all animals were injected with ³H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were done.Based on the results, additional groups were treated at 2.5 and 10%. Five vehicle control animals were similarly treated, but with vehicle alone.
On the basis of observations noted, EC3 value of 5.8% was calculated.
According to the classification criteria for skin sensitisation, 4-chlororesorcinol is likely to be considered as a strong skin sensitiser, as the EC3-value is found to be less than 10%.
Reference
Stimulation Index (SI) values:
Concentration |
Stimulation Index |
Test item |
|
2.5% |
1.1 |
5% |
1.5 |
10% |
10.1 |
25% |
16.4 |
50% |
# |
Vehicle |
1.0 |
α-hexylcinnamaldehyde |
|
5% |
1.2 |
10% |
2.7 |
25% |
16.8 |
# animals found dead
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Local Lymph Node Assay (LLNA) was performed on a group of 5 nulliparous and non-pregnant mice to study the skin sensitizing activity of the test materialA12 / SAT 030626 (4-Chlororesorcinol) at concentrations of2.5, 5, 10, 25 and 50%. Vehicle control used was acetone:olive oil (4:1 v/v).
In the main study, three groups of five experimental animals were epidermally exposed to a 5%, 25% and 50% concentration respectively on three consecutive days. Five vehicle control animals were similarly treated, but with vehicle alone (acetone:olive oil (4:1 v/v).
Three days after the last exposure, all animals were injected with ³H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were done.Based on the results, additional groups were treated at 2.5 and 10%. Five vehicle control animals were similarly treated, but with vehicle alone.
On the basis of observations noted, EC3 value of 5.8% was calculated.
According to the classification criteria for skin sensitisation, 4-chlororesorcinol is likely to be considered as a strong skin sensitiser, as the EC3-value is found to be less than 10%.
Migrated from Short description of key information:
4-chlororesorcinol is found to be sensitising to skin.
Justification for selection of skin sensitisation endpoint:
4-chlororesorcinol is considered as a strong skin sensitiser, as the EC3-value is found to be less than 10%, when tested as per Mouse local lymphnode assay (LLNA).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available study indicates that the substance 4-Chlororesorcinol is likely to be classified as a skin sensitiser.
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