Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 310-115-0 | CAS number: 102506-09-2
- 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
In a skin irritation study conducted to OECD test guideline 404 and in compliance with GLP, ALBRITE CIX(N) was not irritating to the eyes (Safepharm, 1992).
[Cyclohexane-1,2 -diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt was found not irritating to the rabbit eye in a test conducted according to OECD guideline 405, and in compliance with GLP (Safepharm, 1982).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.26-2.72 kg
- Housing: individual housing in suspended cages
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 56-67
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- six
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: The patch was secured in place with a strip of Blenderm surgical adhesive tape, the trunk was then wrapped in an elasticated corset for the duration of the exposure.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was gently swabbed away with cotton wool and distilled water.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: Draize, 1959 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average of 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0.6
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: average of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight erythema was noted at four treated skin sites one hour after patch removal and at two treated skin sites at the 24 and 48 hour observations. Very slight oedema was noted at two treated skin sites one hour after patch removal. All treated skin sites appeared normal 72 hours after treatment.
- Other effects:
- No other effects were reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study conducted to OECD test guideline 404 and in compliance with GLP, ALBRITE CIX(N) was not irritating to the rabbit skin.
- Executive summary:
The primary skin irritation/corrosion of ALBRITE CIX(N) in the rabbit (4-hour semi-occlusive application) was investigated in a study performed according to OECD Testing Guideline No. 404 and under GLP. Six rabbits were exposed to 0.5 ml of the test material, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No skin irritation was observed after 4 hours exposure. Based on the results of the study, ALBRITE CIX(N) is considered to be not irritating to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 November 2016 - 22 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in-vitro test
- Strain:
- other: isolated bovine cornea
- Details on test animals or tissues and environmental conditions:
- TEST MATERIAL
- Source: slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands)
- Acclimation period: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions. Then, the corneas were dissected and incubated in incubation medium at 32 +/- 1°C in an incubation chamber for 1 hour.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1°C - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- An amount of 750 µl of either the negative control, positive control or test item was applied directly on the corneas in such a way that the cornea was completely covered.
- Duration of treatment / exposure:
- The corneas were incubated in a horizontal position for 10 +/- 1 minutes at 32 +/- 1°C.
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes at 32+/-1°C.
- Details on study design:
- The aim of this study was to evaluate the ocular irritancy of the test item as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea.
PROTOCOL
- For each treatment group (negative control, positive control and test item), three replicates were used.
- The opacity of each cornea was determined before exposure.
- The corneas were exposed for 10 minutes.
- After the incubation the change in opacity for each individual cornea (including the negative control) was determined.
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated.
INTERPRETATION
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro irritancy score (IVIS)
- A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritant. - Irritation parameter:
- in vitro irritation score
- Value:
- -0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The negative control showed no irritation (mean IVIS was 0.443). The positive control induced a very severe irritation on the cornea, mean IVIS was 195.5. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The mean in vitro irritancy score of the test item was -0.8 after 10 minutes of treatment with the test item.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- ALBRITE CIX(N) is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
- Executive summary:
A GLP compliant in-vitro study was performed according to OECD Guideline 437 in order to evaluate the ocular irritation properties of ALBRITE CIX(N) on an isolated bovine cornea. The possible ocular irritancy of the test item was tested through topical application for approximately 10 minutes. For each treatment group (negative control, positive control and test item), three replicates were used. After removal of the test item and two hours post-incubation, opacity and permeability values were measured. After treatment, the IVIS (in vitro irritancy score) in the controls is within the acceptability criterion. The positive control showed clear irritating effects. ALBRITE CIX(N) showed no effects on the cornea of the bovine eyes. The IVIS score is -0.8 and therefore it can be concluded that ALBRITE CIX(N) is not a severe eye irritant in the BCOP Test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation study was conducted according to OECD test guideline 404. New Zealand white rabbits (3 animals/sex) had 0.5ml undiluted test substance applied to the skin for four hours under a semi-occlusive patch. After four hours the remaining test substance was gently swabbed away. Skin irritation reactions were recorded at 1, 24, 48 and 72 hours after patch removal. There were no overt signs of toxicity recorded. Very slight erythema was noted at four treated skin sites one hour after patch removal and at two treated skin sites at the 24 and 48 hour observations. Very slight oedema was noted at two treated skin sites one hour after patch removal. All treated skin sites appeared normal 72 hours after treatment. Overall, [cyclohexane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt was concluded not to be irritating to the skin.
A GLP compliant in-vitro study according to OECD Guideline 437 was performed in order to evaluate the ocular irritation properties of ALBRITE CIX(N) on isolated bovine cornea. Since ALBRITE CIX(N) showed no effects on the cornea of the bovine eyes, it can be concluded that the test substance is not a severe eye irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
Justification for classification or non-classification
Based on the available skin and eye irritation studies, [cyclohexane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt is not classified for skin or eye irritation under Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.