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EC number: 221-088-9 | CAS number: 3001-98-7
- 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
skin irritation/corrosion: negative (OECD 431, 439)
eye irritation/corrosion: negative (OECD 438)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-06-17 until 2015-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: per guideline study (GLP)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- the deviation from SOP didn't impact the result of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- other: SkinEthic Reconstituted Human Epidermis (RHE)
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- Upon delivery, SkinEthic™ tissues (RHE/S/17) were treated according to the SOP.
At day 18, tissues were transferred to growth culture medium .Tissues were placed in
maintenance culture medium prior to application of test substances. - Details on study design:
- The irritant potential of AFLAMMIT® PCO 962 was tested using the SkinEthic™ RHE model and expressed as a percent of the negative control tissue NC (exposed to Phosphate Buffer Saline, PBS).
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 50
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The viability of the RHE in the presence of the test substance was above 50% at 42 minutes exposure and 42 hours recovery, following analysis by the MTT viability assay.
Therefore, the sample was classified as non-irritant. - Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2015-04-29 until 2015-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: per guideline study (GLP)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- Without impact on the result of the study.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: SkinEthic™ tissues (RHE/S/17)
- Details on test animals or test system and environmental conditions:
- Upon delivery, SkinEthic™ tissues (RHE/S/17) were treated according to the SOP. Tissues were
transferred to 1 mL of maintenance culture media for a minimum of 3h pre-incubation step. - Amount / concentration applied:
- Test materials (20 μl distilled water followed by 20 mg±3 mg) were applied to the RHE tissue (n=2) for 3 minutes and 1 hour at room temperature then rinsed.
- Details on study design:
- The corrosive potential of AFLAMMIT® PCO 962 was tested using the SkinEthic™ RHE model and expressed as a percent of the negative control tissue NC (exposed to ultrapure water).
- Interpretation of results:
- other: non-corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The viability of the RHE in the presence of the test substance was above 50% at 3 minutes and was above 15% after 1 hour exposure, following analysis by the MTT viability assay. Therefore, the sample was classified as non-corrosive.
Referenceopen allclose all
Treatment | Assay acceptance criterion | OD 570nm1 | SD2 |
PBS (NC) | 0.8 <= OD <= 3 | 1.689 | 0.122 |
SDS (PC) | - | 0.020 | 0.001 |
AFLAMMIT® PCO 962 | - | 1.790 | 0.041 |
Treatment | Assay acceptance criterion | Viability %l | SD %2 | I/NI3 |
PBS (NC) | SD <= 18% | 100.0 | 7.22 | NI |
SDS (PC) | SD <= 18% and Viability < 40% |
1.2 |
0.03 |
I |
AFLAMMIT® PCO 962 |
SD <= 18% |
106.0 |
2.42 |
NI |
1: mean of 3 replicates
2: SD: Standard Deviation
3: I: Irritant; NI: Non Irritant
Table 1: Comparative viability results of tested samples.
Treatment | Assay acceptance criterion | 3 minutes OD570nm1 | SD2 | 1hour ODs1onm1 | SD2 |
Distilled water (NC) | 0.8 <= OD <= 3.0 | 2.158 | 0.196 | 2.217 | 0.023 |
Potassium hydroxide 8,0N (PCl | - | 0.028 | 0.011 | 0.043 | 0.012 |
AFLAMMIT® PCO 962 | - | 2.238 | 0.059 | 2.118 | 0.066 |
Treatment | Assay acceptancecriterion | 3 minutes | 1hour | C/NC4 | ||||
Viability%1 | SD%2 | CV3 | Viability%1 | SD%2 | CV3 | |||
Distilled water (NC) | 100 | 9.07 | 9.07 | 100 | 1.05 | 1.05 | NC | |
Potassium hydroxide 8,0N (PC) | 1.3 | 0.49 | 37.7 | 2.0 | 0.54 | 27.0 | C | |
AFLAMMIT® PCO 962 | 103.7 | 2.75 | 2.65 | 95.5 | 3.0 | 3.14 | NC |
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:
- 2016-03-07 until 2016-03-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- To further establish the classification, histopathological observations were made
on two sections of each of the 3 corneas treated with test item (6 sections). - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- chicken
- Strain:
- other: Strain of chicken: ROSS 308; Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Three eyes were treated with 30 mg of powdered test item.
- Duration of treatment / exposure:
- After 10 seconds, the surface of the eyes was
rinsed with physiological saline solution. - Duration of post- treatment incubation (in vitro):
- The control and test eyes were evaluated pre-treatment and at approximately 30, 75,
120, 180 and 240 minutes after the post-treatment rinse. - Details on study design:
- At the end of the evaluation procedures, the corneas were carefully removed from the eyes and
placed individually into labelled containers of preservative fluid (10% neutral buffered
formalin, Manufacturer: Reanal, Batch number: KTM14051, Expiry date: October
2017 for potential histopathology [9,10] and stored at room temperature. - Irritation parameter:
- other: TEST ITEM
- Run / experiment:
- Overall ICE Class:1xI 2xII
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Remarks:
- Overall ICE Class: 3xI
- Positive controls validity:
- valid
- Remarks:
- Overall ICE Class: 1xIII, 2xIV
- Remarks on result:
- other: Based on this in vitro eye irritation assay in the isolated chicken eyes test with AFLAMMIT PCO 962, the test item is not classified as a severe irritant and not classified as non-irritant.
- Remarks:
- It is concluded that further information is required for classification.I
- Other effects / acceptance of results:
- HISTOPATHOLOGY
Semi-quantitative microscopic evaluation was performed on the cornea in the ICET.
The classification of histopathology findings was performed based on two publications,
M.K. Prinsen et all. (Toxicology in Vitro 25 (2011), 1475-1479) and Elodie Cazelle et
all/ Toxicology in Vitro 28 (2014), 657-666.
The negative control 0.9 % Sodium chloride (Salsol solution) cornea showed no
abnormalities. Positive control, Imidazole was associated with moderate epithelial
erosion. No compromised Bowman’s or basement membrane as well as no endothelial
changes were recorded.
AFLAMMIT PCO 962 produced very slight vacuolation (15A, 15B) or very slight
erosion (16A) of the corneal epithelium. The 16B, 17A and 17B samples did not show
significant changes No stromal and endothelial changes were observed as well as no
effects on integrity of basement, Bowman’s and Descemet’s membranes. - Interpretation of results:
- other: CLP criteria are not met.
- Conclusions:
- Based on this in vitro eye irritation assay in the isolated chicken eyes test with AFLAMMIT PCO 962, the test item is not classified as a severe irritant. It is concluded that further information is required for classification.
To further establish the classification, histopathological observations were made on two sections of each of the 3 corneas treated with test item (6 sections). Microscopic evaluation showed very slight vacuolation (15A and 15B) or very slight erosion (16A) of the corneal epithelium. The 16B, 17A, 17B samples did not show significant changes. No stromal or endothelial changes were observed as well as no effects on integrity of basement, Bowman’s and Descemet’s membranes.
Based on the data the CLP criteria for classification are not met.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Based on the available data, the substance is not classified for skin irritation/corrosion according to Regulation (EC) No 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.
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