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EC number: 200-090-3 | CAS number: 51-34-3
- 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
According to REACH Annex VII column 2 no skin irritation/corrosion test has to be conducted as the substance is classified as acute dermal toxic cat. 1 (H310) according to CLP regulation Annex VI.
Based on a available in vitro test according to OECD 437 (BCOP) the substance has to be classified as eye irritant cat. 1 (H318).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as acute toxicity by the dermal route (Category 1)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- 2016-08-09 to 2016-08-11
- 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)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued June 05, 2015
- Specific details on test material used for the study:
- SOURCE OF COLLECTED EYES
- Source: Slaughterhouse, Germany
- Storage, temperature and transport conditions of ocular tissue: transported in HBSS containig strep /Pen on ice to the
laboratory
- Time interval prior to initiating testing: corneae were isolated inmediatedly after arrival
of the eyes, corneae were directly used in the BCOP test on the same day
- indication of any existing defects or lesions in ocular tissue samples: eyes presenting defects were discarded - Species:
- cattle
- Strain:
- other: cornea
- Details on test animals or tissues and environmental conditions:
- Invitro- Justification of the test method and considerations regarding applicability: The Bovine Corneal Opacity and Permeability (BCOP) test (OECD TG 437; TM B.47) is an in vitro test for the identification of substances inducing serious eye damage, recommended for use as part of a tiered-testing strategy for regulatory classification and labelling.- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live- :isolated corneas obtained as by -product from animals freshly slaughered. The fresh eyes were trasnported in HBSS containing Pen/Stre on ice to the laboratoriy. Inmediadely after arrival of the eyes the conrea preparation was initieated including:examination for defects and any defective eyes were discared.The coreas was excised leaving a 2 to 3 mm rim of sclera and stored in a petri dish containig HBSS and posterior mounted on corneal holders . The corneas (which are free of defects were incubated for one hour at 32 °C +-1
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.75 mL
- suspended with physiological saline 0.9% NaCl (B. Braun Melsungen lot no. 1406787) to gain a 20% concentration
- Duration of post- treatment incubation (in vitro):
- After 4 hours +- 5 minutes incubation at 32+-1 °C either test substance and the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of substance, the cormea was finally rinsed with complete RPMI (without phenol red)
- Number of animals or in vitro replicates:
- 3 corneas for the test item, 3 corneas as negative controls treated with physiological saline 0.9%NaCL, 3 corneas as positive controls treated with imidazole 20% in physiological saline 0.9% Na Cl
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: yes
QUALITY CHECK OF THE ISOLATED CORNEAS: yes
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: yes
POSITIVE CONTROL USED: yes
APPLICATION DOSE AND EXPOSURE TIME: 4 hours ± 5 minutes
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: three times with MEM
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacimeter (BASF-OP3.0, Duratec GmbH)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [Jenway 6405 UV/VIS spectrophotometry
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: yes - Irritation parameter:
- in vitro irritation score
- Value:
- 107.01
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current hystorical mean and therefore the assay is considered to be valid. See other information on results, table 4. The negative control responses result in opacity and permeability values less than the established upper limits of backround bovine cormeas treated with the negative control. All three corneas applicated with the test item showed an all over opacity of the tissue. The mean in vitro irritation score was calculated : 107.01
Visual observation: all 3 corneas treated with Scopolamine showed an allower opacity of the tissue. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- All three cormeas applicated with the test item showed an all over opacity of the tissue. The mean in vitro irritation score was calculated to be 107.01. According to the evaluation criteria of the in vitro BCOP test (OECD 437), the test item was classified into UN GHS category 1.
Reference
Table1: Opacity
Cornea No. |
Test item |
Initial Opacity |
Final Opacity |
Change of Opacity Value |
Corrected Opacity value |
1 |
Negative Control |
1.64 |
1.97 |
0.33 |
|
2 |
1.53 |
1.86 |
0.33 |
|
|
3 |
1.64 |
2.05 |
0.41 |
|
|
MV |
1.60 |
1.96 |
0.36 |
|
|
1 |
Positive Control |
2.58 |
102.31 |
99.73 |
99.37 |
2 |
2.54 |
97.64 |
95.10 |
94.74 |
|
3 |
2.85 |
86.34 |
83.49 |
83.13 |
|
MV |
2.66 |
95.43 |
92.77 |
92.41 |
|
1 |
Test item |
1.82 |
107.77 |
105.95 |
105. 59 |
2 |
0.56 |
66.06 |
65.50 |
65.14 |
|
3 |
0.81 |
54.77 |
53.97 |
53.61 |
|
MV |
1.06 |
76.20 |
75.14 |
74.78 |
Table 2: Permeability
Cornea No. |
Test item |
OD490 |
Corrected OD490 value |
1 |
Negative Control |
0.050 |
|
2 |
0.035 |
|
|
3 |
0.048 |
|
|
MV |
0.044 |
|
|
1 |
Positive Control |
3.355 |
3.311 |
2 |
3.495 |
3.451 |
|
3 |
3.260 |
3.216 |
|
MV |
3.37 |
3.326 |
|
1 |
Test item |
1.830 |
1.786 |
2 |
2.140 |
2.096 |
|
3 |
2.610 |
2.566 |
|
MV |
2.193 |
2.149 |
Table 3: In Vitro Irritation Score
Cornea No. |
Test item |
OD490 |
Corrected OD490 value |
IVIS |
1 |
Negative Control |
0.33 |
0.050 |
|
2 |
0.33 |
0.035 |
|
|
3 |
0.41 |
0.048 |
|
|
MV |
0.36 |
0.044 |
1.02 |
|
1 |
Positive Control |
99.37 |
3.311 |
|
2 |
94.74 |
3.451 |
|
|
3 |
83.13 |
3.216 |
|
|
MV |
92.41 |
3.326 |
142.30 |
|
1 |
Test item |
105. 59 |
1.786 |
|
2 |
65.14 |
2.096 |
|
|
3 |
53.61 |
2.566 |
|
|
MV |
74.78 |
2.149 |
107.01 |
Table 4: Historical mean In Vitro Irritation Score of the Positive Control
|
IVIS Positive Control |
Mean value (MV) |
125.73 |
Standard Deviation (SD) |
17.05 |
MV-2xSD |
91.64 |
MV-2xSD |
159.83 |
Number of replicates providing Historical Mean: 15 |
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
According to CLP regulation Annex VI column the substance is classified as acute dermal toxic cat. 1 (H310) hence a skin irritation study is not needed.
Based on a available test according to OECD 437 (BCOP) the substance has to be classified as eye irritant cat. 1( H318).
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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