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EC number: 700-945-5 | CAS number: -
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 28 August 1985 and 4 October 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with a method similar to an existing guideline with some details not reported
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. 40 CFR Section 163.81-6 (b)(6)(ii) Federal Register August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of November 1982
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study conducted prior to regulatory guidelines
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Animals (300 to 500 g) house and maintained in accordance with standards set forth in the Guide for the Care an Use of Laboratory Animals (DHEW Publication No. 8-23 and were acclimated 7 days prior to testing and individually identified by toe clipping. The animals were housed in stainless steel cages with elevated wire mess floors (3-5 animals per cage). Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne Guinea Pig Formula and tap water ad libitum.
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 50% initially and then 25% on the remaining 8 days of induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 50% initially and then 25% on the remaining 8 days of induction
- No. of animals per dose:
- 12
- Details on study design:
- Prior to initiation of the main study, a preliminary study was conducted at 50% and 25 % to determine the induction and challenge concentration to be used in the main study. Because no skin irritation was observed after 24 hours at either concentration, 50% was selected as the concentration to start the study. The test material as prepared was dosed at 0.5 ml.
In the induction phase of the main study, a group of 12 male albino guinea pigs was clipped over a wide area (and repeated as needed). a dose of 0.5 ml of the prepared test material at a 50% dilution was applied to the test site, covered with a guaze patch, and then covered with an impervious wrapping. Because irritation (barely perceptible and well-defined erythema) was observed at 24 hours following the first of nine days of dosing, the induction concentration for the remaing 8 application days for the induction and the challenge application were changed to 25%. After 6 hours following each daily induction dosing the patch was removed and the animals were allowed to rest for at least one day. Following the rest period another application was applied to the site using a fresh sample. After the ninth (final) application, the animals were allowed to rest 2 weeks. At the termination of the rest period a challenge application was applied to a different site from the original on each animal the skin reactions were then scored at at 24 and 48 hours following the challenge according to the method of Draize. - Challenge controls:
- No Naive control; 12 animals for concurrent positive control
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene 0.1% in 25% ethanol:0.9% saline
- Positive control results:
- Erythema 24 hours: 8/12 with barely perceptable irritation (score = 1); 2/12 with well-definded erythema (score = 2). Erythema 48 hours: 4/12 with barely perceptable irritation (score = 1); 3/12 with well-definded erythema (score = 2). No edema was observed in any animal
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.15
- No. with + reactions:
- 2
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.15. No with. + reactions: 2.0. Total no. in groups: 12.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 3
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 3.0. Total no. in groups: 12.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on EU CLP Regulation No. 1272/2008 this product is not classified for skin sensitization.
- Executive summary:
Prior to initiation of the main study, a preliminary study was conducted at 50% and 25 % to determine the induction and challenge concentration to be used in the main study. Because no skin irritation was observed after 24 hours at either concentration, 50% was selected as the concentration to start the study. The test material as prepared was dosed at 0.5 ml. In the induction phase of the main study, a group of 12 male albino guinea pigs was clipped over a wide area (and repeated as needed). a dose of 0.5 ml of the prepared test material at a 50% dilution was applied to the test site, covered with a gauze patch, and then covered with an impervious wrapping. Because irritation (barely perceptible and well-defined erythema) was observed at 24 hours following the first of nine days of dosing, the induction concentration for the remaing 8 application days for the induction and the challenge application were changed to 25%. After 6 hours following each daily induction dosing the patch was removed and the animals were allowed to rest for at least one day. Following the rest period another application was applied to the site using a fresh sample. After the ninth (final) application, the animals were allowed to rest 2 weeks. At the termination of the rest period a challenge application was applied to a different site from the original on each animal the skin reactions were then scored at at 24 and 48 hours following the challenge according to the method of Draize. No evidence of skin sensitization was observed. All scores at the 24 and 48 hour observation in the challenge phase were zero in all animals (0/12). Evidence of well-defined erythema (score = 2) was observed in 2/12 animals at 24 hours and 3/12 animals at 48 hours in the challenge phase with the 0.1% concurrent positive control indicating that the test was valid. Based on EU CLP Regulation No. 1272/2008 this product is not classified for skin sensitisation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Prior to initiation of the main study, a preliminary study was conducted at 50% and 25 % to determine the induction and challenge concentration to be used in the main study. Because no skin irritation was observed after 24 hours at either concentration, 50% was selected as the concentration to start the study. The test material as prepared was dosed at 0.5 ml. In the induction phase of the main study, a group of 12 male albino guinea pigs was clipped over a wide area (and repeated as needed). A dose of 0.5 ml of the prepared test material at a 50% dilution was applied to the test site, covered with a gauze patch, and then covered with an impervious wrapping. Because irritation (barely perceptible and well-defined erythema) was observed at 24 hours following the first of nine days of dosing, the induction concentration for the remaining 8 application days for the induction and the challenge application were changed to 25%. After 6 hours following each daily induction dosing the patch was removed and the animals were allowed to rest for at least one day. Following the rest period another application was applied to the site using a fresh sample. After the ninth (final) application, the animals were allowed to rest 2 weeks. At the termination of the rest period a challenge application was applied to a different site from the original on each animal the skin reactions were then scored at at 24 and 48 hours following the challenge according to the method of Draize. No evidence of skin sensitization was observed. All scores at the 24 and 48 hour observation in the challenge phase were zero in all animals (0/12). Evidence of well-defined erythema (score = 2) was observed in 2/12 animals at 24 hours and 3/12 animals at 48 hours in the challenge phase with the 0.1% concurrent positive control indicating that the test was valid. Based on EU CLP Regulation No. 1272/2008 this product is not classified for skin sensitization.
Migrated from Short description of key information:
The substance is not sensitising (0/12 sensitisation rate) in a guinea pig study.
Justification for classification or non-classification
Following challenge with 25% test material in mineral oil, all scores at the 24 and 48 hour observation in the challenge phacse were zero in all animals (0/12). No evidence of skin sensitization was observed; evidence of well-defined erythema (score = 2) was observed in 2/12 animals at 24 hours and 3/12 animals at 48 hours.
Under these test conditions, test item is not classified as sensitizing to the skin according to the CLP Regulation (EC) No.1272/2008.
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