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EC number: 908-998-8 | 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Skin irritation: 2 in vivo studies available: corrosive; 1 in vitro study available: corrosive, Cat 1B
Eye irritation: 2 studies available: corrosive
There are two in vivo studies and one in vitro study available on
the skin irritancy potential. A 1:10 dilution of the test item was
tested for its skin irritant properties in 3 or 5 Yellow-silver strain
rabbits. The studies were similar to OECD Guideline 404. Effects on the
skin (bloody and cracky skin) were observed in most of the animals after
application. Therefore, it is concluded that the undiluted registration
substance is corrosive.
In a Corrositex test performed with the test item, the substance was
applied to an artificial bio-barrier membrane In this study under the
given conditions the test substance showed corrosive effects. The test
substance is classified as “CORROSIVE”, subcategory 1B according to the
UN GHS, as the mean time to activate the CDS was > 3 – 60 min (category
1). The test substance is therefore assigned to Packing Group 2 and to
EU Risk-Phrase (R 34).
There are in vivo two studies available on the eye irritancy potential. A 1:10 dilution of test item was tested for its eye irritant properties in 3 or 5 Yellow-silver strain rabbits. The studies were similar to OECD Guideline 405.
The application of a 1:10 dilution of the test substance to the eyes of rabbits lead to slight to moderate opacity, reddening and swelling of the conjunctivae.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-12-04 to 2014-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany
- Test system:
- artificial membrane barrier model
- Source species:
- other: Bio-barrier membrane
- Details on animal used as source of test system:
- n.a.
- Justification for test system used:
- commonly accepted for classication of corrosive substances to Cat. 1A, 1B or 1C
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- This assay is composed of three different steps:
1. Qualification
This step ensures that the sample is compatible with the CORROSITEX™ system. 150 µL of the test substance are added to the Qualify test tube. Solids are shaken to dissolve, if necessary. For immiscible liquids and insoluble solids the vial is shaken and let stand for one minute. If the colour or consistency of the CDS changes at the sample/testing fluid interface, the test material is qualified for the assay. If no reaction is observed within five minutes, the sample is not qualified for the CORROSITEX™ Assay.
2. Categorisation
This step establishes the category for cut-off times for the sample. 150 µL of the test substance are added to the tubes labeled Tube A and Tube B. After shaking a colour change in either of the tubes is matched to the corresponding colour charts on the CORROSITEX™ Testing Protocol Poster. Test materials having high acid/alkaline reserves are defined as Category 1 materials, while those with low acid/alkaline reserves are defined as Category 2 materials. If no colour change is observed in either tube, CONFIRM reagent is added to Tube B. After shaking, the resulting colour is matched to the colour chart on the CORROSITEX™ Testing Protocol Poster.
If the test item has strong colouring or shows other characteristics impairing a clear categorization according to the colour chart, the pH value can be measured in the tubes A and B and is used to confirm/determine the category of the test item
3. Classification
This step determines the appropriate Packing Group for the test sample. The CDS vials are warmed to room temperature (17 - 25˚C) before using. Vials 1 - 4 are utilized for sample replicate testing.The vial labeled (+) was utilized for a positive control sample, the vial labeled (-) for a negative control. The vial labeled C served as a CDS colour control. One BIOBARRIER disc was added on top of the first vial. 500 µL of the test item were applied by five steps per 100 µL with a positive displacement-pipette on the top of the BIOBARRIER disc and starting time was recorded with the first 100 µL. The total application has taken 30 seconds. This step was repeated for the remaining vials, staggering each start time by e.g. 10 seconds. The start time difference for each vial was subtracted from the final time to determine the net response time. As soon as a reaction had been observed, the time was recorded. - Control samples:
- other: Negative control: 10% citirc acid, positive control: 85% phosphoric acid
- Amount/concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- min. 240 minutes
- Duration of post-treatment incubation (if applicable):
- n.a.
- Number of replicates:
- 4
- Amount / concentration applied:
- TEST SYSTEM
- Bio-barrier membrane
TEST MATERIAL
- Amount applied: 500 µL - Observation period:
- 4 hours
- Details on study design:
- This assay is composed of three different steps:
1. Qualification
This step ensures that the sample is compatible with the CORROSITEX™ system. 150 µL of the test substance are added to the Qualify test tube. Solids are shaken to dissolve, if necessary. For immiscible liquids and insoluble solids the vial is shaken and let stand for one minute. If the colour or consistency of the CDS changes at the sample/testing fluid interface, the test material is qualified for the assay. If no reaction is observed within five minutes, the sample is not qualified for the CORROSITEX™ Assay.
2. Categorisation
This step establishes the category for cut-off times for the sample. 150 µL of the test substance are added to the tubes labeled Tube A and Tube B. After shaking a colour change in either of the tubes is matched to the corresponding colour charts on the CORROSITEX™ Testing Protocol Poster. Test materials having high acid/alkaline reserves are defined as Category 1 materials, while those with low acid/alkaline reserves are defined as Category 2 materials. If no colour change is observed in either tube, CONFIRM reagent is added to Tube B. After shaking, the resulting colour is matched to the colour chart on the CORROSITEX™ Testing Protocol Poster.
If the test item has strong colouring or shows other characteristics impairing a clear categorization according to the colour chart, the pH value can be measured in the tubes A and B and is used to confirm/determine the category of the test item
3. Classification
This step determines the appropriate Packing Group for the test sample. The CDS vials are warmed to room temperature (17 - 25˚C) before using. Vials 1 - 4 are utilized for sample replicate testing. Controls are set-up in parallel to the test item in order to confirm the validity of the test: positive control, negative control and one colour control. One BIOBARRIER disc was added on top of the first vial. 500 µL of the test item were applied by five steps per 100 µL with a positive displacement-pipette on the top of the BIOBARRIER disc and starting time was recorded with the first 100 µL. This step was repeated for the remaining vials, staggering each start time by e.g. 10 seconds. The start time difference for each vial was subtracted from the final time to determine the net response time. As soon as a reaction had been observed, the time was recorded. - Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- mean of 4 replicates
- Value:
- 20.92
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD 435
- Conclusions:
- In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1B according to the UN GHS, as the mean time to activate the CDS was > 3 – 60 min, (category 1). The test substance is therefore assigned to Packing Group 2 and to EU Risk-Phrase (R 34).
- Executive summary:
The potential of the test substance to induce skin corrosion was analysed by using the “In Vitro Membrane Barrier Test (CORROSITEX™ Assay)”, comprising a Chemical Detection System covered by a bio-barrier membrane.
The test substance Hordaphos CC MIN proved its ability to activate the CDS and was subsequently subjected to the timescale category test. The test substance was applied undiluted atop thebio-barrier membraneand the timerequired to activate the CDS was measured in four replicates. The mean time was compared to the given thresholds (see Table 1).
The test substance was compatible with the CORROSITEX™ Assay, as assessed in the qualification step. The categorization step and the classification step could be performed.
A direct colour change was observed in tube A and the category was read from the CORROSITEX™ colour chart. The chemical has been categorized to category 1.
In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1B according to the UN GHS, as the mean time to activate the CDS was > 3 – 60 min, (20.92 ± 0.60 min.) (category 1). The test substance is therefore assigned to Packing Group 2 and to EU Risk-Phrase (R 34).
The controls confirmed the validity of the study. The test substance qualified for the CORROSITEX™ Assay, as assessed in the qualification test. The positive control activated the CDS between 3 - 60 min. (12.33 min.), the negative control did not activate the CDS before 60 min. (88.78 min.).
This study satisfies the requirement for Test Guideline OECD 435 for in vitro Membrane Barrier Test Method for Skin Corrosion.
Reference
Qualification Test / Categorization Test
The test substance was compatible with the CORROSITEX™ Assay, as assessed in the qualification step. A direct colour change was observed in tube A and the category was read from the CORROSITEX™ colour chart. The chemical has been categorized to category 1.
Classification Test
CORROSITEX™ time [min] | Colour change | consistency change | |
Replicate 1 | 20.17 | yes | no |
Replicate 2 | 20.75 | yes | no |
Replicate 3 | 21.17 | yes | no |
Replicate 4 | 21.58 | yes | no |
Mean +/- SD | 20.92 +/- 0.60 | ||
Positive Control | 12.33 | yes | no |
Negative Control | 88.78 | yes | no |
The mean time, required to activate the CDS was 20.92 +/- 0.60 min.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
With reference to the presence of bloody, scabby skin after application to rabbit skin the registration substance has to be classified as corrosive to the skin, Cat. 1 (H314 – Causes severe skin burns and eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
It is concluded that the undiluted registration substance has to be classified as irritant to the eyes (H318 - Causes serious eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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