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EC number: 293-165-5 | CAS number: 91052-08-3
- 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
Skin, rabbit (OECD 404): not irritating
Eye, rabbit (OECD 405): not irritating
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (Limited details on materials and methods, and results, no test substance volume.)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- yes
- Remarks:
- Limited details on materials and methods, and results; no test substance volume.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Observation period:
- 72 h
- Number of animals:
- 3 (sex not specified)
- Details on study design:
- OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 3/3 animals showed mild erythema (score 1) at the 1-h reading time point, which persisted in 1/3 animals until the 24-h reading time point. All effects had cleared within 48 h after patch removal. No oedema was observed in any animal at any time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 404, which specifies that a volume of 0.5 mL should be used. The result of the study is therefore considered to be acceptable.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (Limited details on materials and methods, no anaesthetics were used, unknown test substance volume.)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adpoted Oct 2012
- Deviations:
- yes
- Remarks:
- Limited details on materials and methods, test substance volume, no anaesthetics were used.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 (sex not specified)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- At the 1-h reading time point, 3/3 rabbits exhibited moderate to severe conjunctivae (score 2-3). 3/3 animals had mild-moderate conjunctivae (score 1-2) at the 24-h reading time point (the score was reduced in 2/3 animals at this time point). The conjunctivae persisted in 1/3 animals until 48 h after treatment, while the effect had cleared in the remaining 2/3 animals. All signs of conjunctivae were reversed within 72 h after treatment. 2/3 animals showed chemosis at the 1-h reading time point; the chemosis had cleared completely within 24 h after treatment. No effects were repoted on the cornea or iris in any animal at any reading time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 405, which specifies that a volume of 0.1 mL should be used. The result of the study is therefore considered to be acceptable.
Reference
Table 1. Individual eye irritation scores
Rabbit #
|
Time
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 h |
2 |
0 |
0 |
0 |
24 h |
2 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
1.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 h |
2 |
1 |
1 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.33 |
0.0 |
0.0 |
0.0 |
|
3
|
1 h |
3 |
1 |
0 |
0 |
24 h |
2 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.67 |
0.0 |
0.0 |
0.0 |
*(24h+48h+72h)/3
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study assessing the skin irritation potential of Dub TGI 24 was performed according to a protocol similar to OECD guideline 404 (please refer to IUCLID section 7.3.1). An unknown volume of the test substance was applied for 4 hrs to the skin of 3 New Zealand White rabbits under semiocclusive conditions. The untreated skin site of the animals served as the control. The skin reactions (erythema and oedema) were scored 1, 24, 48 and 72 hrs after patch removal. 3/3 animals showed mild erythema (score 1) at the 1-hr reading time point, which persisted in 1/3 animals until the 24-hrs reading time point. All effects were reversible within 48 hrs after patch removal. No oedema was observed in any animal at any time point. The individual mean erythema scores over the 24, 48 and 72 hors reading time points were 0, 0.33 and 0, and the edema scores were 0, 0 and 0, respectively. In conclusion, the test substance is considered to be non-irritating to the skin.
Eye irritation
An eye irritation study was performed with Dub TGI 24 similar to OECD guideline 405 (please refer to IUCLID section 7.3.2). The undiluted test substance was instilled into one eye of 3 New Zealand White rabbits. The other eye remained untreated and served as the control. Examination and scoring of effects on the eyes was performed at intervals of 1, 24, 48 and 72 hrs after test substance application. At the 1-hr reading time point, 3/3 rabbits exhibited moderate to severe conjunctivae (score 2-3). 3/3 animals had mild-moderate conjunctivae (score 1-2) at the 24-h reading time point, (the score was reduced in 2/3 animals). The conjunctivae persisted in 1/3 animals until 48 hrs after treatment, while the effect had cleared in the remaining 2/3 animals. All signs of conjunctivae were reversed within 72 hrs after treatment. 2/3 animals showed chemosis at the 1-hr reading time point; the chemosis had cleared completely within 24 hrs after treatment. No effects were reported on the cornea or iris in any animal at any reading time point. The mean chemosis, cornea and iris scores over 24, 48, and 72 hrs were 0 for all 3 animals, respectively. The mean score for conjunctivae over 24, 48, and 72 hrs was 1.0, 0.33 and 0.67 for the 3 animals.In conclusion, the test substance was not considered irritating to the eye.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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