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EC number: 208-235-2 | CAS number: 517-23-7
- 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:
A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method
EPISKIN-SM. The study was conducted in accordance with OECD TG 431. Following exposure with the test substance after 4 hours, the mean cell viability was 91.6% compared to the negative control value. Therefore, the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method EpiDerm™. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 39 % (rounded). The test item was thus shown to be irritating to reconstructed human skin in vitro.
Eye Irritation:
The irritation effects of the test item were evaluated according to the OECD No. 438. After the zero reference measurements, the eyes were held in a horizontal position and the treatments (test item, positive, nagative controls) were applied onto the centre of the cornea such that the entire surface of the cornea was covered in all cases. After 10 seconds, the surface of the eyes was rinsed with isotonic saline solution. Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) evaluated.
The results from all eyes used in the study met the quality control standards. The negative control and positive control results were in good correlation with the historical control data. Thus, the experiment was considered to be valid.
Based on this in vitro eye irritation test in isolated chicken eyes, the test item is not classified as severe irritant and not classified as non-irritant.
According to OECD TG 405 a single instillation of 0.1 ml of the undiluted test item into the conjunctival sac of three rabbits caused slight conjunctival erythema accompanied by edema and corneal opacity which disappeared completely in two animals after one week, while the eye of the third animal had cleared after two weeks. For these reactions a primary irritation score of 3.25 was calculated, corresponding to the classification "moderately irritating". This evaluation and is consistent with the in vitro result.
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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted in 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test method
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µL
NEGATIVE CONTROL
- Amount(s) applied: 30 μL
POSITIVE CONTROL
- Amount(s) applied: 30 μL
- Concentration: 5% aqueous solution - Duration of treatment / exposure:
- 60 min (35 min at 37 °C and 25 min at room temperature)
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- triplicates for treatment and control groups
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 38.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- other: positive
- Conclusions:
- In this in vitro skin irritation test in EpiDerm™ tissue in accordance with OECD 439 and in compliance with GLP, the mean cell viability compared to the negative control was 38.5% after 60 min exposure with the test substance. All validity criteria were within acceptable limits. In conclusion, the test substance was irritating to human epidermis tissue. However, since the RhE test method cannot resolve between irritation and corrosion, further information on skin corrosion would be required to decide on its final classification or hazard potential.
- Executive summary:
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method EpiDerm™.
The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 39 % (rounded). The test item was thus shown to be irritating
to reconstructed human skin in vitro.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM (Manufacturer: SkinEthic, France
- Tissue batch number(s):Batch No.:14-EKIN-016, Expiry Date: 12 May 2014) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 μl
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied: 50 μl
- Concentration (if solution): 0.9% NaCl in water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μl - Duration of treatment / exposure:
- The plates with the treated epidermis units were incubated for 4 hours (±10 min) at room temperature (22.4-23.9°C) covered with the plate lids.
- Number of replicates:
- Two replicates per test item per time point were used. Two negative controls and two positive controls were also run in the assay. Furthermore, as the test item had an MTT interacting potential, two additional test item-treated killed epidermis and two negative control treated killed epidermis were used in the study.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- expousre period: 4 hours
- Value:
- 91.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item had no colouring potential or intrinsic colour. Therefore, the Non Specific Colour % (NSC %) determination was not necessary.
However, colour change (purple) was observed after three hours of incubation of the test item in MTT solution, thus the test material interacted with the MTT. Therefore, additional controls and data calculations were necessary to exclude the false estimation of viability. - Interpretation of results:
- other: negative
- Executive summary:
A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method
EPISKIN-SM. The study was conducted in accordance with OECD TG 431.
Following exposure with the test substance after 4 hours, the mean cell viability was 91.6% compared to the negative control value. Therefore, the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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
- 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 Ocular Corrosives and Severe Irritants)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: chicken
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 30 µL
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- Three test item treated eyes, three positive control treated eyes and one negative control eye were examined during the study.
- Details on study design:
-
NEGATIVE CONTROL USED
: physiological saline (0.9% NaCl solution)
POSITIVE CONTROL USED : benzalkonium chloride solution (5%, w/v)
APPLICATION DOSE AND EXPOSURE TIME : 30 µl, 10 seconds
OBSERVATION PERIOD : at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: the eyes were rinsed with 20 ml isotonic saline
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- mean
- Value:
- 2.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean at up to 75 min
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean up to 240 min
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- None
- Interpretation of results:
- other: positive
- Conclusions:
- Based on this in vitro eye irritation test in isolated chicken eyes, the test item is not classified as severe irritant and not classified as non-irritant.
- Executive summary:
The irritation effects of the test item were evaluated according to the OECD No. 438. After the zero reference measurements, the eyes were held in a horizontal position and the treatments (test item, positive, nagative controls) were applied onto the centre of the cornea such that the entire surface of the cornea was covered in all cases. After 10 seconds, the surface of the eyes was rinsed with isotonic saline solution. Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) evaluated.
The results from all eyes used in the study met the quality control standards. The negative control and positive control results were in good correlation with the historical control data. Thus, the experiment was considered to be valid.
Based on this in vitro eye irritation test in isolated chicken eyes, the test item is not classified as severe irritant and not classified as non-irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 29.01.-12.02.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml/animal
- Duration of treatment / exposure:
- At least 14 days following instillation (no washout after 24 hours)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 7 and 14 days after administration.
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- To calculate the irritation effect all scores of each animal at each of the following reading times (24, 48, 72 hours) were used in calculating the respective mean values.
The primary irritation score was calculated by totalling the individual cumulative scores at 1, 24, 48 and 72 hours and then divided by the number of figures. - Irritation parameter:
- other: Primary irritation score
- Basis:
- mean
- Time point:
- other: 1/24/48/72 h
- Score:
- 3.25
- Max. score:
- 13
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Generally slight diffuse corneal opacity was observed in the animals nos. 67
(male) and 68 (female) from 1 to 48 hours after treatment. Generally slight
diffuse corneal opacity was observed in the animal no. 69 (female) at 1 to 72
hours. At day 7 slightly spotted diffuse corneal opacity was observed in the
same animal only. - Other effects:
- No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred.
The body weight gain of all rabbits was similar. - Interpretation of results:
- other: positive
- Executive summary:
According to OECD TG 405 a single instillation of 0.1 ml of the undiluted test item into the conjunctival sac of three rabbits caused slight conjunctival erythema accompanied by edema and corneal opacity which disappeared completely in two animals after one week, while the eye of the third animal had cleared after two weeks. For these reactions a primary irritation score of 3.25 was calculated, corresponding to the classification "moderately irritating".
Referenceopen allclose all
Positive Control
Observation Value ICE Class* | Value ICE Class* | ICE Class* |
Mean maximum corneal swelling at up to 75 min | 0% | I |
Mean maximum corneal swelling at up to 240 min | -7% | II |
Mean maximum corneal opacity | 3.50 | IV |
Mean fluorescein retention | 2.83 | IV |
Other Observations | Loosening of epithelium was observed in two eyes (at 75 and 120 minutes after the post-treatment rinse) | |
Overall ICE Class* | 2xI 1xIII |
Negative Control
Observation Value ICE Class* | Value ICE Class* | ICE Class* |
Mean maximum corneal swelling at up to 75 min | 0% | I |
Mean maximum corneal swelling at up to 240 min | 0% | I |
Mean maximum corneal opacity | 0.00 | I |
Mean fluorescein retention | 0.00 | |
Other Observations | None | |
Overall ICE Class* | 3xIII |
Test item
Observation Value ICE Class* | Value ICE Class* | ICE Class* |
Mean maximum corneal swelling at up to 75 min | 0% | I |
Mean maximum corneal swelling at up to 240 min | 0% | I |
Mean maximum corneal opacity | 0.50 | III |
Mean fluorescein retention | 2.33 | |
Other Observations | None | |
Overall ICE Class* | 2xI 1xIII |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the study results for skin irritation/corrosion a classification in Category 2 (H 315: Causes skin irritation) according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
Based on the study results for eye irritation a classification in Category 2 ( H319: Causes serious eye irritation) according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
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