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EC number: 233-195-8 | CAS number: 10061-01-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 22 November 1988 to 23 December 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted to an appropriate test guideline with no or minor deviations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted
Test material
- Reference substance name:
- cis-1,3-dichloropropene
- IUPAC Name:
- cis-1,3-dichloropropene
- Details on test material:
- From Appendix A:
Batch an other numbers SNC No. 1986: 88009
Toxicology reference No. St88/253Source: Shell Nederland Raffindarerij BV Rotterdam
Date received: 18 Oct 1988
Appearance: clear colourless liquid
Analysis: 94.51-97.51% cis isomer with 1.5% trans isomer
Density: 1.224 g/mL @ 15.2 ºC
Date released: 18 Nov 1988
Storage: dark at ambient temperature
Stability: stable for the duration of the study (no changes from 21 Nov 1988 to 19 Jan 1989
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Guinea-pigs (Dunkin-Hartley strain) were obtained from Porcellus Ltd. Their bodyweight was between 300 and 400 g and their age 5 to 9 weeks at the time of receipt. The animals were housed initially in single sex groups of ten animals. After an acclimatisation period of at least two weeks they were re-allocated to cages accommodating two or three animals. Hanging stainless steel cages with wire-mesh floors were used, each measuring 54 cm x 31 cm x 36 cm, Sawdust-filled trays for excreta were placed beneath each cage and changed three times weekly. Pelleted diet (SG1 with vitamin C supplement, Grain Harvesters Ltd.) and water from the public supply were provided ad libitum. There were no excursions of animal room environmental conditions beyond target values of 19 to 23 °C and 30% to 70% R.H. that were considered to have influenced the outcome of the study. Lighting (fluorescent tube) was automatically controlled to provide a 12 hour day and 12 hour night. Animals assigned to the study were identified by cage-labels displaying animal numbers, experiment number, sex and treatment regime and, within the cage, by coloured dye-marking of the fur.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Remarks:
- and/or freund's complete adjuvant
- Concentration / amount:
- Intradermal induction: 0.1% (m/v)in corn oil/FCA
Topical induction: 5% (m/v) in corn oil
Topical challenge: 2.5% (m/v) in corn oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Remarks:
- and/or freund's complete adjuvant
- Concentration / amount:
- Intradermal induction: 0.1% (m/v)in corn oil/FCA
Topical induction: 5% (m/v) in corn oil
Topical challenge: 2.5% (m/v) in corn oil
- No. of animals per dose:
- 10/sex/dose (5/sex negative controls)
- Details on study design:
- Induction: 2 rows of intradermal injectiosn were made one on either side of the midline as follows (controls received solvents only):
0.1 mL FCA
0.1 mL 0.1% cis-1,3-DCP in FCA
0.1 mL 0.1% cis-1,3-DCP in 50:50 FCA/corn oil
One week after intradermal injection, the same area of skin was shaven and a 16cm2 patch includin 0.3 mL of 5% test material in corn oil was applied occlusively for 48 hr with negative controls with vehicle only.
Challenge:
3 weeks after intradermal induction, hair was shaved and a 4cm2 patch containing 0.1mL of 2.5% cis-1,3DCP in corn oil was applkied and covered occlusively for 24 hr - Challenge controls:
- Control group animals were created with the same formulation of test material that was applied to test group animals.
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: after patch removal
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- 1/20 Beet red area with well defined edge; 11/20 pink/red area with defined edges; 6/20 slight redness, edges not defined
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: after patch removal. . Hours after challenge: 0.0. Group: test group. Dose level: 2.5%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: 1/20 Beet red area with well defined edge; 11/20 pink/red area with defined edges; 6/20 slight redness, edges not defined.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- 9/20 pink/red area with defined areas; 11/20slight redness, edges not defined
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: 9/20 pink/red area with defined areas; 11/20slight redness, edges not defined.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 8/20 pink/red area with well defined edges, 10/20 slight redenss, edges not defined; 2/20 no difference from surrounding skin
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: 8/20 pink/red area with well defined edges, 10/20 slight redenss, edges not defined; 2/20 no difference from surrounding skin.
- Reading:
- other:
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0 (corn oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no difference from surrounding skin
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 0.0. Group: negative control. Dose level: 0 (corn oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no difference from surrounding skin.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 (corn oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no difference from surrounding skin
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 (corn oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no difference from surrounding skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 (corn oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no difference from surrounding skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 (corn oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no difference from surrounding skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- All 20 test animals showed postive responsies 24 h after removal of the challenge patches and 18 showed postive responses after 48 h. The substance is considered to be a skin sensitiser under the conditions of the test.
- Executive summary:
A GLP-compliant guinea pig maximisation test has been conducted according to OECD Guideline 406. All of the twenty test animals showed postive responses at 24 and/ or 48 hours after removal of the challenge patch. The substance is considered to be a skin sensitiser under the conditions of the test.
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