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EC number: 617-343-2 | CAS number: 82530-64-1
- 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:
- supporting study
- Study period:
- 2000-05-26 until 2000-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Good laboratory practice guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Testing done in 2000, LLNA was not available then.
Test material
- Reference substance name:
- 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
- IUPAC Name:
- 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
- Details on test material:
- - Name of test material (as cited in study report): 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
- Physical state: brown liquid
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 1/99
- Expiration date of the lot/batch: 2000-07-31
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan strain
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL ltd. Füllinsdorf, Switzerland
- Weight at study initiation: 397-544 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Concentrations: 100% , 50%, 20%, 10%, 5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Concentrations: 100% , 50%, 20%, 10%, 5%
- No. of animals per dose:
- 10 in main study, 5 in the control
- Details on study design:
- RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main study. The selection of concentrations was based on the following criteria:
- The concentrations are well tolerated by the animals.
-For the induction exposures: the highest possible concentration that produced mild to moderate irritation (grades 2-3)
_for challenge exposure: The maximum non-irritant concentration.
Series of test substance concentrations were tested. Practical feasibility of administration determined the highest starting concentration for each route. The stating and subsequent concentrations were taken from the series: 100% , 50%, 20%, 10%, 5%, 2% 1% and if neded further lower concentrations using the same steps.
Intradermal injections: Initially, a series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The resulting dermal reactions were assessed 24 and 48 hours after treatment. Based on the results in the initially treated animals two other animals were treated in a similar manner with four concentrations at a later stage.
Epidermals application: A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) pera nimal to the clipped flank. The initially used animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water.
The results were assessed for irritation 24 and 48 hours after exposure. Based on the results in the initially treated animals two other animals were treated in a similar manner with four concentrations at a later stage.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1: The scapular region was clipped and three pairs of intradermal injections (0.1 ml/site) were made in this area as follows:
a) A 1:1 mixture of Freuds' Complete Adjuvant with water for injections
b) The test substance at a 10 % concentration
c) A 1:1 mixture of the stest substance at twice the concentration used in B) and Freud' Complete Adjuvant.
Day 3: The dermal reactions caused by the intradermal injections were assessed for irritation
Day 8: The scapular area between the injection sites was clipped and subsequently treated with0.5 ml of a 50% test substance concentration. The dressing was removed after 48 hours exposure the skin cleaned of residual test substance using water and the dermal rections caused by the epidermal exposure were assessed for irritation.
The control animals were treated as described for the experimental animals except that instead of the test substance vehicle alone was administered.
B. CHALLENGE EXPOSURE
Day 22 One flank of all animals was clipped and treated by epidermal application of a 50% test substance concentration and the vehicle (0.15 ml each).The dressing was removed after 24 hours exposure the skin cleaned of residual test substance using water. The trated sites were assessed for challenge rections 24 and 48 hours after removel of the dressing. - Positive control substance(s):
- yes
- Remarks:
- alpha Hexylcinnamicaldehyde
Results and discussion
- Positive control results:
- The reliability control worked as expected. The test was prepared separately in October/November 1999 with 10% .alpha.-Hexylcinnamicaldehyde.0/10 animal showed score 3 reactions, 3 showed score 2 reactions and 3 showed score 1 reactions after 24 h. 4 animals showed no reaction.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 10
- 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: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 10
- 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: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- 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: negative control. 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:
- negative control
- 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: negative control. 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:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is sensitizing to the skin in a OECD 406 Guinea Pig Maximation Test under the conditions used.
- Executive summary:
A guinea pig maximization test on 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester) according to OECD 406 did show clearly sensitizing effects when applied. The controls worked as expected.
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