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EC number: 236-004-6 | CAS number: 13092-66-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo. Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 02 January 2013 and 21 January 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of GLP inspection: 10 July 2012 Date of Signature on GLP certificate: 30 November 2012
Test material
- Reference substance name:
- Magnesium bis(dihydrogenorthophosphate)
- EC Number:
- 236-004-6
- EC Name:
- Magnesium bis(dihydrogenorthophosphate)
- Cas Number:
- 13092-66-5
- Molecular formula:
- H3O4P.1/2Mg
- IUPAC Name:
- magnesium bis(dihydrogenorthophosphate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification : IP 31: Magnesium bis(dihydrogenorthophosphate)
CAS number : 13092-66-5
Description : white powder
Batch number : Laboratory preparation 11.10.11
Purity : >98%
Date received : 02 October 2012
Expiry date : not supplied
Storage conditions : room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: 2.70 or 2.83 kg
- Housing: The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet (e.g. ad libitum): ad libitum (2930 Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES:
From: day 1 To:day 7
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes.
- Concentration (if solution): Undiluted and used as supplied
VEHICLE
- Amount(s) applied (volume or weight with unit):
Not applicable - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Approximately 1 hour and 24, 48 and 72 hours following treatment. An additional observation was made on Day 7 to assess the reversibility of the ocular
effects. - Number of animals or in vitro replicates:
- 2 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, one additional animal was treated. )
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not applicable
- Time after start of exposure:
Not applicable
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 72826 Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: Initial pain reaction = 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 72873 Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: Inital pain reaction = 2
- Irritation parameter:
- iris score
- Basis:
- animal: 72826 Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effect observed
- Irritation parameter:
- iris score
- Basis:
- animal: 72873 Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effect observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 72826 Male
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 72873 Male
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 72826 Male
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 72873 Male
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2.
No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye one hour after treatment.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment
and at the 24 and 48-Hour observations with minimal conjunctival irritation noted at the
72-Hour observation.
Both treated eyes appeared normal at the 7-Day observation. - Other effects:
- Bodyweight
Both animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Interpretation of Results
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score
for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system ( Modified Kay and Calandra Interpretation of Eye Irritation Test was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit.
If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.
Table1 Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
72826 Male |
72873 Male |
||||||||
IPR= 2 |
IPR = 2 |
|||||||||
Time After Treatment |
1 |
24 |
48 |
72 |
7 Days |
1 |
24 |
48 |
72 |
7 days |
CORNEA |
|
|
||||||||
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
||||||||
D |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
||||||||
A = Redness |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
1 |
1 |
0 |
B = Chemosis |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
1 |
1 |
0 |
C = Discharge |
3 |
2 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
Score (A + B + C) x 2 |
14 |
12 |
8 |
4 |
0 |
12 |
10 |
8 |
4 |
0 |
Total Score |
19 |
12 |
8 |
4 |
0 |
12 |
10 |
8 |
4 |
0 |
IPR= Initial pain reaction
Table 2 Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
||||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
|
72826 Male |
19 |
12 |
8 |
4 |
0 |
72873 Male |
12 |
10 |
8 |
4 |
0 |
Group Total |
31 |
22 |
16 |
8 |
0 |
Group Mean Score |
15.5 |
11.0 |
8.0 |
4.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not meet the criteria for classification as irritant according to Regulation (EC) No. 1272/2008 (EU CLP). This study is conducted according to the appropriate guidelines (OECD 405) and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint. Study is sufficient for classification and labelling purposes, in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Result
A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both treated eyes appeared normal at the 7-Day observation.
Conclusion
The test item produced a maximum group mean score of 15.5 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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