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EC number: 606-195-4 | CAS number: 189956-45-4
- 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
In a K2 in vivo skin irritation study in New Zealand White Rabbits according to OECD Guideline 404 and EU Method B.4, T002487 was found to be a mild irritant with a primary irritation index of 0.2. Based on CLP Regulation (EC) No 1272/2008, the test item is considered not to be classified (score < 2.3).
Eye Irritation:
In a K2 Rabbit Enucleated Eye Test (REET) test assessing the ocular irritancy potential by applying the test material onto the cornea of the enucleated eye, T002487 is considered to have the potential to cause severe ocular irritancy in vivo and should be classified as Category 1 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations and the criteria of the CLP regulation (EC) No 1272/2008.
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
- Study period:
- 2004-11-10 to 2004-11-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Study is conducted according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); however, the test substance is not adequately characterized and insufficient information is provided on the test animals.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Insufficient information on the test substance and test animals.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Insufficient information on the test substance and test animals.
- GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
- Specific details on test material used for the study:
- no data
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- source: 3 male NewZealand White Rabbits, no further data on test animals
ENVIRONMENTAL CONDITIONS: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact
- Vehicle:
- not specified
- Controls:
- other: Untreated skin areas of the test animals served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data
VEHICLE: no data - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: semi-occlusive, no further data
REMOVAL OF TEST SUBSTANCE: no data
OBSERVATION TIME POINTS
- Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
SCORING SYSTEM:
- according to Draize
- Primary Irritation Index
0 = Non-irritant
>0 - 2 = Mild irritant
>2 - 5 = Moderate irritant
>5 - 8 = Severe irritant - Irritation parameter:
- erythema score
- Basis:
- animal: 61
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal: 61
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- An isolated incidence of very slight erythema was noted at one treated skin site at the 24-hour observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be a mild irritant with a primary irritation index of 0.2. Based on the criteria of the CLP regulation (EC) No 1272/2008, the test item is considered not to be classified (score < 2.3).
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
61 Male |
67 Male |
68 Male |
|||
Erythema/Eschar Formation |
1 Hour |
0 |
0 |
0 |
(0) |
24 Hour |
0 |
0 |
1 |
1 |
|
48 Hour |
0 |
0 |
0 |
(0) |
|
72 Hour |
0 |
0 |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
(0) |
24 Hour |
0 |
0 |
0 |
0 |
|
48 Hour |
0 |
0 |
0 |
(0) |
|
72 Hour |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72 Hour Readings |
1 |
||||
Primary Irritation Index (S/6) and Classification |
1/6=0.2 |
||||
Mild Irritant |
( ) = Total values not used for calculation of primary irritation index
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:
- FRom 2004-11-01 to 2004-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- While only a study summary was available for review which provided limited details on the test substance and methodology, sufficient information was provided to deem the study reliable with restrictions.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The ocular irritancy potential of the test material was assessed using the rabbit enucleated eye test (REET) SPL Standard Test Method 569.04. This method involved the application of the test material onto the cornea of the enucleated eye.
- GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.
- Specific details on test material used for the study:
- no data
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: New Zealand White rabbits, no further data on test animals
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): the enucleated eyes were maintained at a temperature of 32°C +/- 1.5°C within the superfusion apparatus. - Vehicle:
- not specified
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item, which had been found to weigh approximately 60 mg
- Concentration (if solution): no data
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 0.9% - Duration of treatment / exposure:
- single application
- Number of animals or in vitro replicates:
- 3 enucleated eyes were treated with the test item and 2 enucleated eyes were treated with the control.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no data
OBSERVATION TIME POINTS
- corneal opacity and corneal epithelium condition: 60, 120, 180 and 240 min post dosing
- fluorescein uptake: 240 min post dosing
- corneal swelling: 60, 120 and 240 min post dosing
SCORING SYSTEM:
The direct effect of the test substance on the cornea was assessed by evaluation of corneal thickness, corneal opacity, alteration of corneal epithelium and fluorescein uptake, throughout the duration of the study.
TOOL USED TO ASSESS SCORE:
no data - Irritation parameter:
- cornea opacity score
- Remarks:
- cloudiness/ mean of 3 eyes after 60, 120, 180 and 240 min post dosing
- Run / experiment:
- 1
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- area/mean of three eyes after 60, 120, 180 and 240 min post dosing
- Run / experiment:
- 1
- Value:
- 2.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- other: Fluorescein uptake
- Remarks:
- intensity/mean of three eyes
- Run / experiment:
- 1
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: Fluorescein uptake
- Remarks:
- area/mean of three eyes
- Run / experiment:
- 1
- Value:
- 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean of three eyes 60 min post dosing
- Run / experiment:
- 1
- Value:
- 13.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean of three eyes 120 min post dosing
- Run / experiment:
- 1
- Value:
- 15.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean of three eyes 240 min post dosing
- Run / experiment:
- 1
- Value:
- 19.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- negative control eyes:
- corneal opacity: 0 (mean of 2 eyes)
- corneal epithelium condition: normal (2 eyes)
- fluorescein uptake: 0 (mean of 2 eyes)
- corneal swelling: 1.0 at 60 min post dosing, 1.1 at 120 minutes post dosing and 1.3 at 240 minutes post dosing
Corneal epithelium condition was normal at all timepoints for all test item treated eyes. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material is considered to have the potential to cause severe ocular irritancy in vivo.
Reference
Table 1. Results obtained for corneal opacity at 60, 120, 180, and 240 minutes post exposure.
|
Corneal Opacity |
|||||||
Observation Period (minutes post dosing) |
||||||||
60 |
120 |
180 |
240 |
|||||
Cldy |
Area |
Cldy |
Area |
Cldy |
Area |
Cldy |
Area |
|
Test Eyes |
1 |
3 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
3 |
1 |
2 |
1 |
1 |
1 |
1 |
|
1 |
2 |
1 |
2 |
1 |
1 |
1 |
1 |
|
Control Eyes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cldy = Corneal opacity
Table 2. Results obtained for corneal epithelium condition at 60, 120, 180, and 240 minutes post exposure.
|
Corneal Epithelium Condition |
|||
Observation Period (minutes post dosing) |
||||
60 |
120 |
180 |
240 |
|
Test Eyes |
Normal |
Normal |
Normal |
Normal |
Normal |
Normal |
Normal |
Normal |
|
Normal |
Normal |
Normal |
Normal |
|
Control Eyes |
Normal |
Normal |
Normal |
Normal |
Normal |
Normal |
Normal |
Normal |
Table 3. Results obtained for fluorescein uptake 240 minutes post exposure.
|
Fluorescein Uptake (240 minutes) |
||||
Test Eyes |
Control Eyes |
||||
Int |
1 |
1 |
1 |
0 |
0 |
Area |
4 |
1 |
1 |
0 |
0 |
Int = Intensity of fluorscein uptake
Table 4. Results obtained for corneal swelling at 60, 120, and 240 minutes post exposure.
|
Corneal Swelling (%)(minutes post dosing) |
||
60 |
120 |
240 |
|
Test Eyes |
13.7 |
15.3 |
19.6 |
Control Eyes |
1.0 |
1.1 |
1.3 |
Test eyes results are the mean of three eyes while control eyes are the mean of two eyes
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Sanders (2004) investigated acute dermal irritation of T002487 in 3 male New Zealand White rabbits after 4 hours of exposure to 0.5 g of test item. Skin reactions were recorded 1, 24, 48 and 72 hours after administration. There was an isolated incidence of very slight erythema (0.33) noted at one treated skin site at the 24-hour observation but was fully reversible within 48 hours. Under the conditions of this study, the test item was found to be a mild irritant. However, based on the criteria of the CLP Regulation (EC) No 1272/2008, the test item is considered not to be classified (score < 2.3).
An in vitro skin irritation study was waived based on the justification that adequate data from an in vivo skin irritation study are available.
Eye irritation:
The rabbit enucleated eye test (REET) was performed by Sanders (2004) to assess the ocular irritancy potential of T002487. 0.1 mL of test item (which weighed approximately 60 g) was applied onto the cornea of three enucleated eyes, obtained from the New Zealand White strain of rabbit. Corneal opacity (60, 120, 180 and 240 minutes after application), corneal swelling (60, 120 and 240 minutes after application) and fluorescein uptake (240 minutes after application) were observed and scored. The corneal opacity mean score of 3 eyes was 1, fluorescein uptake mean score was 1 and the percent corneal swelling mean of 3 eyes at 60, 120 and 240 minutes was 13.7, 15.3 and 19.6, respectively. The test item is considered to have the potential to cause severe ocular irritancy in vivo.
Justification for classification or non-classification
Skin irritation:
According to the in vivo acute dermal irritation study, no skin irritation was noted for T002487. The test item did not meet the criteria for classification as irritant or corrosive according to the criteria of the CLP regulation (EC) No 1272/2008.
Eye irritation:
According to the in vitro eye irritation study (REET), T002487 induced ocular irritation and should be classified for eye damage Category 1 according to the criteria of the CLP regulation (EC) No 1272/2008.
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