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EC number: 285-332-6 | CAS number: 85068-73-1
- 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: Data waiving (study scientifically not necessary): According to column 2 of REACH Annex VII, the study does not need to be conducted because an acute toxicity study by the dermal route is available for the test substance and does not indicate skin irritation up to 2 000 mg/kg body weight (limit dose test).
Serious eye damage/eye irritation: Key study. Method according to OECD guideline 437, GLP study. The test item showed no effects on the cornea of the bovine eye. The test item does not require classification for eye irritation or serious eye damage.
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 an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to column 2 of REACH Annex VII, the study does not need to be conducted because an acute toxicity study by the dermal route is available for the test substance and does not indicate skin irritation up to 2 000 mg/kg body weight (limit dose test). - Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
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:
- 18 February 2020
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Müller Fleisch GmbH, Industriestraße 42, 75217 Birkenfeld, Germany.
- Number of animals: Not specified. 9 corneas received for the test.
- Characteristics of donor animals (e.g. age, sex, weight): Between 12 and 60 months old.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour and 5 minutes.
- Time interval prior to initiating testing: the test was performed on the day of the transport.
- indication of any existing defects or lesions in ocular tissue samples: None of the corneas received showed tissue damage; therefore, all corneas were used.
- Indication of any antibiotics used: Penicillin 100 U/mL, Streptomycin 100 µg/mL. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL.
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 10 min.
- Duration of post- treatment incubation (in vitro):
- 2 hours.
- Number of animals or in vitro replicates:
- 3 replicates.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1ºC) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1ºC.
MEM: Minimum Essential Medium
cMEM (complete MEM): MEM supplemented with sodium bicarbonate, L-glutamine and 1% fetal calf serum
QUALITY CHECK OF THE ISOLATED CORNEAS
Corneas which show any tissue damages or an opacity greater than seven opacity units should be discarded.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: yes, Hank’s Balanced Salt Solution (HBSS).
POSITIVE CONTROL USED: yes, Dimethylformamide, undiluted.
APPLICATION DOSE AND EXPOSURE TIME: 750 μL (test item, negative and positive controls), 10 min exposure.
TREATMENT METHOD: closed chamber method
POST-INCUBATION PERIOD: yes, 2 hours.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times or until no visual evidence of test chemical was observed.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer BASF OP 3.0.
- Corneal permeability: passage of sodium fluorescein dye (optical density at 492 nm) measured with microtiter plate photometer (Anthos Reader 2010 Flexi).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: as indicated in the TG (see table below). - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 0.07
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.59)
- Positive controls validity:
- valid
- Remarks:
- (86.97)
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0.05
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.54)
- Positive controls validity:
- valid
- Remarks:
- (69.04)
- Irritation parameter:
- other: permeability
- Run / experiment:
- mean
- Value:
- 0.001
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.0037)
- Positive controls validity:
- valid
- Remarks:
- (1.1952)
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no.
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- A test is considered acceptable if: the positive control gives an IVIS that falls within two standard deviations of the current historical mean and negative/solvent controls gives values of opacity and permeability lower than upper limits for background values.
- Acceptance criteria met for negative control: yes, HBSS response resulted in opacity and permeability values that are less than established upper limits for negative control opacity (2.36) and permeability values (0.03)
- Acceptance criteria met for positive control: yes, IVIS score of dimethylformamide was 86.97 which falls between two standard deviations of the historical mean i.e. 56.56 – 139.37. - Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Under the conditions of this study, the test item showed no effects on the cornea of the bovine eye. The test item does not require classification for eye irritation or serious eye damage.
- Executive summary:
An in vitro Bovine Corneal Opacity and Permeability (BCOP) study was conducted in order to determine the potential severe eye damaging effects of the test item according to the OECD guideline 437 under GLP conditions. Three sets consisting of three corneas each were tested using the closed chamber method: the first set was the negative control and was treated with 750 μL Hank’s Balanced Salt Solution (HBSS); the second set was the positive control and was treated with 750 μL of dimethylformamide undiluted and the third set was treated with 750 μL of test item without dilution. The corneas were exposed for 10 min at 32ºC. After removal of the test item and 2 hours post-incubation, opacity of the corneas and fluorescein permeability were measured. Negative control showed No category (IVIS score 0.59) and resulted in opacity and permeability values that are less than the established upper limits for the background values. The positive control induced serious eye damage on the cornea (IVIS score 86.97) and was within two standard deviations of the current historical mean. The test item showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 0.07. According to OECD Guideline 437, a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
Reference
Table 1.1. Illuminance Values (Unit: LUX)
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
1052 |
1045 |
1060 |
1014 |
1022 |
1024 |
1024 |
1033 |
1035 |
(I) Measured values after exposure |
1038 |
1035 |
1044 |
998 |
1012 |
1009 |
382 |
414 |
382 |
Table 1.2. Opacity Values Negative Control
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.44 |
2.72 |
2.12 |
Opacity after exposure |
3.00 |
3.12 |
2.76 |
Opacity Difference |
0.56 |
0.41 |
0.64 |
Mean Opacity Difference |
0.54 |
Table 1.3. Opacity Values Test Item and Positive Control
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
4.01 |
3.67 |
3.58 |
3.58 |
3.21 |
3.12 |
Opacity |
4.70 |
4.09 |
4.22 |
75.85 |
66.94 |
75.85 |
Opacity |
0.70 |
0.43 |
0.64 |
72.27 |
63.73 |
72.72 |
Opacity |
0.16 |
-0.11 |
0.10 |
71.73 |
63.20 |
72.19 |
Mean Opacity |
0.05 |
69.04 |
Table 2.1. Optical density at 492 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.040 |
2. Measurement |
0.040 |
3. Measurement |
0.035 |
Mean |
0.038 |
Table 2.2. Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
|
1. Measurement |
0.045 |
0.040 |
0.042 |
0.048 |
0.042 |
0.039 |
1.068 |
1.250 |
1.383 |
2. Measurement |
0.043 |
0.040 |
0.041 |
0.049 |
0.043 |
0.037 |
1.095 |
1.243 |
1.380 |
3. Measurement |
0.044 |
0.041 |
0.042 |
0.046 |
0.045 |
0.038 |
1.083 |
1.246 |
1.387 |
|
|||||||||
1. Measurement – blank |
0.0067 |
0.0017 |
0.0037 |
0.0097 |
0.0037 |
0.0007 |
1.0297 |
1.2117 |
1.3447 |
2. Measurement – blank |
0.0047 |
0.0017 |
0.0027 |
0.0107 |
0.0047 |
-0.0013 |
1.0567 |
1.2047 |
1.3417 |
3. Measurement – blank |
0.0057 |
0.0027 |
0.0037 |
0.0077 |
0.0067 |
-0.0003 |
1.0447 |
1.2077 |
1.3487 |
Mean of each replicate |
0.0057 |
0.0020 |
0.0033 |
0.0093 |
0.0050 |
-0.0003 |
1.0437 |
1.2080 |
1.3450 |
Mean of the 3 replicates |
0.0037 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.0057 |
0.0013 |
-0.0040 |
1.0400 |
1.2043 |
1.3413 |
Corrected mean of the 3 replicates |
-- |
0.0010 |
1.1952 |
Table 3. IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.65 |
0.59 |
22.78% |
0.44 |
|||
0.69 |
|||
Test Item |
0.25 |
0.07 |
255.88% |
-0.09 |
|||
0.04 |
|||
Positive Control |
87.33 |
86.97 |
6.36% |
81.26 |
|||
92.31 |
Note: the high relative standard deviation of the IVIS of the test item is due to mathematical reasons, as the respective means are very small.
*IVIS = Mean Opacity value + (15 × Mean Permeability value)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Skin irritation/corrosion: Based on the available data, the substance is not classified for skin irritation according to CLP Regulation no. 1272/2008.
Serious eyes damage/eye irritation: Based on the available data, the substance is not classified for eye irritation according to CLP Regulation no. 1272/2008.
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