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EC number: 480-340-8 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 7th, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAm Test Method Evaluation Report: Appendix G = ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)
- Principles of method if other than guideline:
- SOP 118 00 830, edition 1, dated 10 April 2008.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 480-340-8
- EC Name:
- -
- Cas Number:
- 156157-97-0
- Molecular formula:
- C12H30Cl2N2Na2O14
- IUPAC Name:
- Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium
Constituent 1
Test animals / tissue source
- Species:
- other: Lohmann Leghorn chicken's eggs
- Details on test animals or tissues and environmental conditions:
- - Description of the cell system used: chlorionallantoic membrane (CAM) of 9 day incubated chicken eggs; freshly laid Lohmann Leghorn chicken eggs were obtained from the LSL Rhein Main Geflugelvermehrungsbetried (Dieburg, Germany) and incubated for eight days.
- Incubation of eggs: during incubation the eggs were rotated to prevent an attachment of the embryo to one side of the egg.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 300 μl of the test item were measured using a centrifuge vial. The amounts were weighed before application to test system: 91.4; 106.0; 91.2; 105.7; 107.3; 91.9 mg. - Duration of treatment / exposure:
- incubation time: 300 seconds.
- Number of animals or in vitro replicates:
- six replicates for test item, three replicates for each positive control, three replicates for negative control.
- Details on study design:
- CAM PREPARATION: 24 hours before the start of the experiment (eight days after obtaining the eggs), the chicken eggs were candled and non-viable eggs were discarded. The rest of the eggs were placed upward in the incubator until the next day. On the day of the test, the eggs were removed from the incubator for use in the assay. At first, the eggs were candled and the air bubble was marked. The egg was opened on the air bubble with a forceps. The inner membrane was moistened with 0.9 % NaCl, then the egg was left to stand into the incubatror for 30 minutes. After this period, the solution was decanted and the inner membrane was carefully removed with a forceps.
TREATMENT OF CAM WITH TEST SUBSTANCE: after the preparation of CAM, the test item was given directly onto the CAM surface; 300 μl (approx. 100 mg) were measured using a centrifuge vial. Prior to the application of the test system the amounts were weighed. The test item was applied on the membrane in such a manner that 50 % of the surface of the membrane was covered with test item.
OBSERVATIONS: the reactions on the CAM were observed over a period of 300 seconds. These reactions include: haemorrhage (bleeding from the vessels), vascular lysis (blood vessel disintegration) and coagulation (intra- and extra-vascular protein denaturation). The time for the appearance of each of the noted observations was monitored and recorded in seconds.
DECISION CRITERIA
- The test substance is considered to be irritant to eye according to the irritation score (IS). Between 0 - 1.9 the substance is not irritant, between 2- 4.9 the substance is slightly irritant, between 5 - 8.9 the substance is moderately irritant and between 9 - 21 the substance is severely irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 17.69
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: no signs of irritation were observed. IS for negative control was within the historical control data (0.00).
- Acceptance criteria met for positive control: both positive controls showed severe irritation. IS for both positive controls were within the historical control data 10 -19.
Any other information on results incl. tables
The observations noted with the corresponding calculated irritation scores are presented in the following table.
Table: experimental observations and irritation score.
Test group | Time until Haemorrhage (s) |
Time until |
Time until |
Irritation score | Mean Irritation score |
seconds | seconds | seconds | |||
Negative control | 301 | 301 | 301 | 0.00 | 0.00 |
Negative control | 301 | 301 | 301 | 0.00 | |
Negative control | 301 | 301 | 301 | 0.00 | |
Positive control 0.1 NaOH |
15 | 29 | 40 | 18.94 | 19.03 |
Positive control 0.1 NaOH |
11 | 28 | 39 | 19.06 | |
Positive control 0.1 NaOH |
16 | 27 | 36 | 19.09 | |
Positive control 1% SDS |
14 | 87 | 301 | 9.78 | 10.15 |
Positive control 1% SDS |
14 | 55 | 301 | 10.52 | |
Positive control 1% SDS |
12 | 72 | 301 | 10.16 | |
Test item | 10 | 116 | 65 | 16.25 | 17.69 |
Test item | 8 | 98 | 29 | 17.78 | |
Test item | 9 | 74 | 39 | 18.02 | |
Test item | 9 | 100 | 35 | 17.54 | |
Test item | 10 | 68 | 34 | 18.30 | |
Test item | 9 | 76 | 30 | 18.25 |
Applicant's summary and conclusion
- Interpretation of results:
- other: classified in Category 1 for serious eye damage according to the CLP Regulation (EC) No.1272/2008.
- Conclusions:
- The substance is considered as corrosive to eye.
- Executive summary:
The irritation potential of the substance was assessed in the in-vitro study by detection of damages in blood vessels on the chorionalantoic membrane (CAM) of incubated chicken eggs (nine days old). The reactions on the CAM were observed over a period of 300 seconds and the time of the appearance of haemorrhage, lysis and coagulation were recorded in order to estimate the irritation score. Negative control and two positive controls run in parallel.
Both positive controls induced severe irritation on the blood vessels whereas the negative control showed no irritation. Both positive and negative control data lay within the accepted historical data. A mean IS (of six replicates) of 17.69 was calculated for the test substance.
The substance is considered to be as corrosive to eye.
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