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EC number: 275-604-2 | CAS number: 71550-24-8
- 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
Conflicting results were observed in 3 in vivo studies in rabbits. Depending on the formulation tested 2 tests (Bayer 1985 and Bayer 1984) were negative for skin corrosion, while one test showed corrosion (Bayer 1982). Therefore an in vitro test for skin corrosion was performed. The substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes. The relative mean viability of the test substance treated tissues was 17.4 % for the 3 minutes exposure and 9.5 % for the 60 minutes exposure. Therefore it can be concluded that the substance is corrosive to the skin (Category 1A).
Two in vivo tests for eye irritation showed that the formulations tested were severely eye damaging (Bayer 1982 and Bayer 1985).
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:
- 7 February 2017 to 23 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.40bis of Commission Regulation (EC) No 440/2008, of 30 May 2008,
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: EpiDerm™ Human Skin Mode
- Cell source:
- other: EpiDerm™ Human Skin Mode
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Human Skin Mode (MatTek)
- Tissue batch number(s):23395
- Delivery date: 22 February 2017
- Temperature used during treatment / exposure: 37 °C, 5% CO2
- Temperature of post-treatment incubation (if applicable): 37°C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS: rinsed with PBS and blotted dry
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT
- Incubation time: 3 h at 37 °C, 5% CO2
- Spectrophotometer: plate spectrophotometer using isopropanol as a blank.
- wavelength : 570 nm
TISSUES:
- Fresh tissues: for treatment, negative control and positive control
- N. of replicates : 2/treatment
- Method of calculation used:
TMT/UMT
TMT= test item treated viable
UMT = negative control viable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 experiment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50% (H314 1A), or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15% (H314 1B or 1C)
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15% (not classified as corrosive) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL as such
VEHICLE
- Amount(s) applied (volume or weight with unit): 50 µL distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8.0 N Potassium Hydroxide - Duration of treatment / exposure:
- 3 min and 60 min
- Duration of post-treatment incubation (if applicable):
- The plates was incubated (37 °C, 5% CO2) for 3 hours in presence of MTT. Thereafter tissues were placed in isopropanol for MTT extraction, which was measured in triplicate samples as optical density at 570 nm.
- Number of replicates:
- 2/treatment
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- A 3 minutes exposure
- Value:
- 17.4
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- B 60 minutes exposure
- Value:
- 9.5
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- corrosive
- Other effects / acceptance of results:
- The results were in agreement with the quality criteria:
Negative Control
The absolute OD562 of the negative control treated tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. The mean OD562 of the two negative control tissues should be ≥ 0.8 and ≤ 2.8 for each exposure time, which ensures that the tissue viability meets the acceptance criteria.
Positive Control
Potassium Hydroxide 8.0N solution is used as a positive control. An assay meets the acceptance criterion if mean relative tissue viability of the 60 minute positive control is < 15%.
Coefficient of Variation
In the range 20 and 100% viability, the Coefficient of Variation between tissue replicates should be ≤ 30%. - Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The substance is considered to be corrosive
- Executive summary:
The substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes. As the substance is corrosive no additional controls were included for the observed color interference. The relative mean viability of the test substance treated tissues was 17.4 % for the 3 minutes exposure and 9.5 % for the 60 minutes exposure. Therefore it can be concluded that the substance is corrosive to the skin (Category 1A).
Reference
|
Exposure time |
Mean OD570 |
Relative mean viability |
Negative control |
3 min |
1.724 |
100% |
|
60 min |
1.607 |
100% |
Test substance |
3 min |
0.300* |
17.4% |
|
60 min |
0.153** |
9.5% |
Positive control |
3 min |
0.174* |
10.1% |
|
60 min |
0.054** |
3.4% |
*Correction factor 0.043
** Correction factor 0.043
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 9 November 1982 to 17 November 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lipischen Versuchtierzucht, Hagemann GmbH & Co KG, 4923 Exertal 1
- Weight at study initiation: average 2.5 kg
- Housing: individually
- Diet: SNIFF "mümmel z"(Soest, Westfalen) ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- after 1, 24, 48, 72 hours and on day 8
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein was applied after the 24 hour observation - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- corneal opacity with keratoconus and starting maceration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.9
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- severe irritant effects
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance as tested causes severe eye damage
- Executive summary:
Three rabbits received 0.1 mL of the substance in their eye. Observations at 1, 24, 48 and 72 hours and after 7, 14 and 21 days showed irreversible effects on the cornea, iris and chemosis in all animals. All animals showed corneal opacity with keratoconus and starting maceration (non-reversible). Therefore it is concluded that the substance as tested causes serious eye damage (H318).
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- October-November 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Curchill Ltd, Huntingdon/Interfauna UK Ltd
- Weight at study initiation: 3.0-3.3 kg
- Housing: individually in wire Type III cages
- Diet: SNIFF K4 (Versuchstieren Diäte, Soest, Westfalen) ad libitum
- Water: tap water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2 °C
- Humidity (%): 45-65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: washed with physiological saline (after application of fluorescein)
SCORING SYSTEM: Draize
SCORING TIMES: at 1, 24, 48 and 72 hours and on day 7,14 and 21 after exposure
TOOL USED TO ASSESS SCORE: fluorescein applied after 24 h - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- increased to 3 on day 14 and 21
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- in animal 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- in animal 1 and 3
- Irritant / corrosive response data:
- see table
Fluorescein staining in animal 1 showed damage of the cornea - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance as tested is considered to induce irreversible effects on the eye
- Executive summary:
Three rabbits received 0.1 mL of the substance in their eye. Observations at 1, 24, 48 and 72 hours and after 7, 14 and 21 days showed irreversible effects on the cornea and chemosis in one animal. Therefore it is concluded that the substance as tested causes serious eye damage (H318)
Referenceopen allclose all
Animal no |
1 |
2 |
3 |
||||||||||||
1 |
24 |
48 |
72 |
8 |
1 |
24 |
48 |
72 |
8 |
1 |
24 |
48 |
72 |
8 |
|
cornea |
2 |
2 |
4 |
4 |
4 |
3 |
3 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
iris |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
chemosis |
2 |
4 |
4 |
4 |
4 |
2 |
4 |
4 |
3 |
3 |
3 |
4 |
4 |
4 |
3 |
discharge |
2 |
3 |
3 |
3 |
3 |
2 |
3 |
3 |
3 |
3 |
2 |
2 |
3 |
3 |
2 |
*not scored because of discolouration; corneal opacity with keratoconus and starting maceration (non-reversible)
Animal no |
1 |
|
2 |
|
3 |
|
|||||||||||||||
1 |
24 |
48 |
72 |
7 |
14 |
21 |
1 |
24 |
48 |
72 |
7 |
14 |
21 |
1 |
24 |
48 |
72 |
7 |
14 |
21 |
|
cornea |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
3 |
1 |
1 |
1 |
1 |
0 |
0 |
2 |
1 |
1 |
1 |
1 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
chemosis |
3 |
3 |
3 |
2 |
2 |
2 |
1 |
3 |
3 |
3 |
2 |
1 |
0 |
0 |
3 |
3 |
3 |
3 |
2 |
2 |
0 |
discharge |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
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
Based on the information available the substance needs to be classified as corrosive (H314, category 1A) according to Regulation (EC) No 1907/2006.
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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