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EC number: 262-765-9 | CAS number: 61397-56-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-05-24 to 2006-06-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Comparable to OECD Guideline 404 and EU Guildine B.4 study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 1) the test substance was put on a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm2) to guarantee a good contact and uniform distribution of the test substance on the skin
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 1) the test substance was put on a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm2) to guarantee a good contact and uniform distribution of the test substance on the skin
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from the Swiss GLP Monitoring Authorities
Test material
- Reference substance name:
- cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate
- EC Number:
- 262-765-9
- EC Name:
- cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate
- Cas Number:
- 61397-56-6
- Molecular formula:
- C18H15BrCl2O4
- IUPAC Name:
- [(2R,4R)-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl]methyl benzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-16479671-AAA (T001095)
- Physical state: solid (powder)
- Appearance: White powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
- Age at study initiation: 12-13 weeks (male); 8-9 weeks (female)
- Weight at study initiation: 2463 g (male); 1726 and 2021 g (females)
- Housing: Housed in a wire cage in compliance with AALAC regulations. Animals were housed ndividually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd., Fullinsdorf) and haysticks 4642 (batch no. 77/05, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 8/06) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are archived at RCC Ltd.
- Water: Community tap water from Fullinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
- Acclimation period: From 2006-05-24 to 2006-05-28 under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 17-23 deg C, monitored continuously and values outside of the range may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study.
- Humidity (%): air conditioned with relative humidity between 30-70% monitored continuously and values outside of the range may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study.
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hrs light and 12 hrs dark
IN-LIFE DATES: From: 2006-05-24 To: 2006-06-01
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL purified water
- Concentration (if solution): no data
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: The left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The test substance was applied with a 4 cm x 4 cm surgical gauze patch
- % coverage: no data
- Type of wrap if used: The test substance was applied with a 4 cm x 4 cm surgical gauze patch. The gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
If evident, corrosive or staining properties of the test substance were described and recorded.
Commission Directive 2004/73/EC, April 29, 2004, Grading of Skin Reactions
Erythema and Eschar Formation:
No erythema =0
Very slight erythema = 1
Well-defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beef redness) or eschar formation (injuries in depth preventing erythema) reading = 4
Oedema Formation:
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edges of area well-defined by definite raising) = 2
Moderate oedema (edges raised approximately 1 mm) = 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicaable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Neither alterations of the treated skin were observed, nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test substance of the treated skin was observed.
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test substance is considered to be "not irritating" to rabbit skin, and therefore should not be classified.
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