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EC number: 281-468-5 | CAS number: 83950-14-5
- 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
Endpoint summary
Administrative data
Description of key information
Six male rabbits were dermally exposed to the substance for 24 hours under occlusion. Erythema could not be scored due to staining of the skin. Based on the oedema scores the substance is considered to be irritating to the skin (Bayer 1980).
In a test which is similar to the OECD guidance, the substance as tested (chloride) is considered not irritating to the skin of 6 rabbits exposed (under occlusion) during 24 hours ( Laboratorium für Pharmakolgie und Toxikologie)
The substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes.
Additional controls were included for the observed color interference. The relative mean corrected viability of the test substance treated tissues was 50.7 % for the 3 minutes exposure and 24.2 % for the 60 minutes exposure. Therefore it can be concluded that the substance is not corrosive to the skin (Eurofins 2017).
In a test, similar to OECD 405, on 6 male rabbits, the substance was found to be severely irritating to the eyes. Based on the scores for opacity, and iritis, the substance needs to be classified as eye damaging category 1 (Bayer 1980).
The eye irritancy potential of the substance was investigated in the bovine corneal opacity and permeability assay (Eurofins 2017). All 3 corneas treated with the substance showed strong reddish discolouration of the tissue. The mean in vitro irritation score was calculated: 141.76. Therefore the substance needs to be classified as a category 1 substance.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41 - Method of testing primary irritant substances.
- Principles of method if other than guideline:
- The exposure period was 24 hours.
A test on the abraded skin was included in the study design, but the results are not included in this summary - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippischen Versuchstierzucht Extertal
- Weight at study initiation: average 2.1 kg
- Housing: individual
- Diet: "Mümmel z" (SNIFF Soest Germany) ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days (observations after 30 min (=24 h), 48 and 72 hours and after 8 days)
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: occulsive (chirugical gaze covered with PVC foil kept in place with elastic bandage (Leukoflex and Eloflex)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS: 24, 48 and 72 hours and on day 8
SCORING SYSTEM:
- Method of calculation: similar to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- due to staining of the test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1.83 - <= 2.17
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Indication of irritation which was reversible within 8 days in 2/6 rabbits
The averga oedema score in 2/6 rabbits was > 2.3 (see table) - Other effects:
- no other effects reported
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance is irritating to the skin
- Executive summary:
Six male rabbits were dermally exposed to the substance for 24 hours under occlusion. Erythema could not be scored due to staining of the skin. Based on the oedema scores the substance is considered to be irritating to the skin.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 June 2017 to 27 July 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):25822 and 25823
- Delivery date: 21 June 2017 and 26 July 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: 1 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: 2 experiments
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
NEGATIVE CONTROL
- 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:
- 50.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: colour corrected value
- Remarks:
- corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- B 60 minutes exposure
- Value:
- 43
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: colour corrected value
- Other effects / acceptance of results:
- The results were in agreement with the quality criteria:
Negative Control
The absolute OD570 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 OD570 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:
- other: non-corrosive
- Conclusions:
- The substance is considered to be not corrosive
- Executive summary:
The substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes. Additional controls were included for the observed color interference. The relative mean corrected viability of the test substance treated tissues was 50.7 % for the 3 minutes exposure and 24.2 % for the 60 minutes exposure. Therefore it can be concluded that the substance is not corrosive to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- January 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register: 38 Fed. Reg. 26885 (Sept. 27, 1973).
- Principles of method if other than guideline:
- The test substance was applied to the intact and abraded skin of 6 rabbits. Only the results on the intact skin are reported in this summary.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: 2.3-2.8 kg
- Housing: individually in V2A steel cages (0.4 m2)
- Diet/water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 0.5°C
- Humidity (%): 55 ± 5%
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3 males + 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: linen patch (covered with plastic foil and elastic bandage (Leukoplast, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS: 24, 48 and 72 hours
SCORING SYSTEM: according to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No signs of irritation
- Other effects:
- no other effects noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the test the substance is considered not irritant to the skin
- Executive summary:
In a test which is similar to the OECD guidance, the substance as tested is considered not irritating to the skin of 6 rabbits exposed (under occlusion) during 24 hours.
Referenceopen allclose all
Animal no | 1 | 2 | 3 | |||||||||
24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | |
erythema | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
oedema | 2 | 2 | 2 | 2 | 1 | 0 | 2 | 2 | 1 | |||
Animal no | 4 | 5 | 6 | |||||||||
24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | |
erythema | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
oedema | 3 | 2 | 2 | 3 | 3 | 2 | 1 | 1 | 0 |
Results of 3 min
Name |
Negative Control |
Test Item |
Positive Control |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.238* |
0.984 |
0.184 |
SD OD570 of 2 Replicate Tissues |
0.049 |
0.162 |
0.050 |
TODTT |
- |
0.628 |
- |
Mean Relative Tissue |
100.0 |
79.5 |
14.8 |
Coefficient Of Variation [%]*** |
4.0 |
16.5 |
27.3 |
NSCliving– Corrected Mean Relative Tissue Viability [%] |
- |
50.7 |
- |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is 30%.
Results of 60 min
Name |
Negative Control |
Test Item |
Positive Control |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.376* |
0.592 |
0.120 |
SD OD570 of 2 Replicate Tissues |
0.003 |
0.136 |
0.013 |
TODTT |
- |
0.333 |
- |
Mean Relative Tissue |
100.0 |
43.0 |
8.7** |
Coefficient Of Variation [%]*** |
0.2 |
23.0 |
10.9 |
NSCliving– Corrected Mean Relative Tissue Viability [%] |
- |
24.2 |
- |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the 60 min positive control < 15%,
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is 30%.
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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany (no details)
- Storage, temperature and transport conditions of ocular tissue: transported in HBSS containing Pen/Strep on ice, stored for < 30 min in HBBS
- Time interval prior to initiating testing: incubated in corneal holders in RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine for 1 hour at 32 ± 1 °C
- indication of any existing defects or lesions in ocular tissue samples: any corneas with defects were discarded
- Indication of any antibiotics used: yes see above - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 uL in the anterior chamber of the holder (applied directly onto the cornea due to high viscosity)
- Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- After 10 minutes incubation either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber was refilled with complete RPMI and an illuminance measurement was performed after 2 hours incubation at 32 ± 1 °C .
- Number of animals or in vitro replicates:
- 3 for test substance, 3 for negative controls and 3 for positive controls
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: from slaughter house animals
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS for <30 min. Before the corneas were mounted in corneal holders with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS: at arrival in the laboratory, before use and after exposure visually inspection for defects
NUMBER OF REPLICATES: 3/group
NEGATIVE CONTROL USED: physiological saline
POSITIVE CONTROL USED: ethanol
APPLICATION DOSE AND EXPOSURE TIME: 750 uL during 10 min at 32 ± 1 °C
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes 2 hours at 32 ± 1 °C
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: washed at least three times with MEM (containing phenol red). The washing medium was thereafter free of coloring, but the corneas showed a strong reddish discoloration..
- POST-EXPOSURE INCUBATION: 2 hours at 32 ± 1 °C
METHODS FOR MEASURED ENDPOINTS:
Before exposure: An initial measurement was performed on each of the corneas using an opacitometer. Three corneas with illuminance readings approximately equivalent to the median illuminance of all corneas were selected as negative-control corneas. The illuminance of each cornea was read and recorded. Only corneas that had an initial illuminance reading I > I0/1.1651 lux were used for the assay. The medium was removed from the anterior chamber and replaced with the test item or control.
After exposure: Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber was refilled with complete RPMI and an illuminance measurement was performed after 2 hours incubation at 32 ± 1 °C. Also, each cornea was observed visually and pertinent observations were recorded.
After the illuminance measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 mL of a 4 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ± 1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer
- Corneal opacity: BASF opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured at 490 nm (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: according to the guidance
IVIS UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
> 55 Category 1 - Irritation parameter:
- in vitro irritation score
- Value:
- 141.46
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- the tissue treated with the substance showed strong reddish discolouration and therefore it cannot be excluded that these have interfered with the opacity readings
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results of the test the substance is considered to be severely irritant to the eyes
- Executive summary:
The eye irritancy potential of the substance was investigated in the bovine corneal opacity and permeability assay.
All 3 corneas treated with the substanceshowed strong reddish discolouration of the tissue.
The following mean in vitro irritation score was calculated: 141.76
The in vitro score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42 - Test for eye irritants.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippischen Versuchstierzucht Extertal 1
- Weight at study initiation: average 2.1 kg
- Housing: individual
- Diet: "Mümmel z" (SNIFF Soest Germany) ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 uL
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: similar to Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope (fluorescein on day 8) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.17
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: at the 24 hour observation scoring was not posible due to discoloration due to the substance
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Indication of severe eye damage
The scores are based on 6 rabbits - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance formulation is consideed to cause severe eye damage
- Executive summary:
In a test on 6 male rabbits similar to OECD 405, the substance was found to be severely irritating to the eyes. Based on the scores for opacity, and iritis, the substance needs to be classified as eye damaging category 1.
Referenceopen allclose all
In Vitro Irritation Score
Group |
Cornea no. |
Corrected opacity |
Corrected OD490 |
IVIS |
Negative control |
1 |
-0.25 |
0.004 |
|
|
2 |
0.80 |
0.005 |
|
|
3 |
1.17 |
0.008 |
|
|
Mean value |
0.57 |
0.006 |
0.66 |
Positive control |
1 |
23.92 |
1.436 |
|
|
2 |
31.18 |
1.102 |
|
|
3 |
29.69 |
1.749 |
|
|
Mean value |
28.26 |
1.429 |
49.70 |
Test substance |
1 |
153.43 |
0.344 |
|
|
2 |
127.34 |
0.369 |
|
|
3 |
129.19 |
0.308 |
|
|
Mean value |
136.65 |
0.341 |
141.76 |
historical controls
|
IVIS positive control ethanol |
Mean value |
48.40 |
SD |
9.98 |
Mean value + 2*SD |
28.44 |
Mean value – 2*SD |
68.37 |
Based on 45 replicates |
Animal no | 1 | 2 | 3 | |||||||||
24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | |
cornea | 4 | 4 | 4 | 4 | 3 | 3 | 4 | 4 | 3 | 3 | 4 | 4 |
iris | 2 | 2 | 1 | 2 | 2 | 1 | 1 | 2 | 2 | 2 | 2 | 2 |
conjunctivae | ||||||||||||
redness | NA | 1 | 1 | 1 | NA | 1 | 1 | 3 | NA | 1 | 1 | 1 |
chemosis | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 |
discharge | 2 | 3 | 3 | 3 | 2 | 3 | 3 | 3 | 2 | 3 | 3 | 3 |
Animal no | 4 | 5 | 6 | |||||||||
24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | |
cornea | 4 | 4 | 4 | 4 | 2 | 3 | 3 | 3 | 2 | 3 | 3 | 3 |
iris | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
conjunctivae | ||||||||||||
redness | NA | 1 | 1 | 1 | NA | 2 | 2 | 3 | NA | 1 | 1 | 1 |
chemosis | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 3 | 4 | 4 | 4 | 4 |
discharge | 2 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The in vivo skin irritation study with the substance is considered to represent a worst case (24 hours exposure under occlusion). In a similar in vivo study with the chloride, no skin irritation was seen. The amount of acetic acid present in the substance could give rise to classification as skin irritant 2. Therefore in view of the inconsistent study results and the presence of acetic acid, the substance will be classified for skin irritation as a precautionary measure.
Justification for classification or non-classification
Based on the available information, the substance needs to be classified for as H315: causes skin irritation (category 2) and H318: Causes serious eye damage (category 1) according to EC Regulation No 1272/2008 (CLP).
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