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EC number: 429-100-6 | CAS number: 23911-56-0
- 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
In a skin irritation study in rabbits according to OECD guideline 404, the test item was found to be not irritating to the skin.
In an eye irritation study according to OECD guideline 405, the test item was found to be not irritating to the rabbit's eye.
Conclusion: The test item was not skin or eye irritating in vivo.
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:
- 1997-02-24 to 1997-02-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-12-29
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-2.3 kg
- Housing: The rabbits were caged individually in PPO/HIPS Noryl®) cages (floor area: 2576 cm^2) with perforated floor. The trays under the cages were cleaned 2-3 times a week.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- other: Ethanol 96% and diethylphthalate (DEP) in ratio 1 : 1 (w/w)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 100%, 25%, 10%, 5% and 1%
VEHICLE
- Amount applied: 0.5 mL
- Concentration: Ethanol 96% and diethylphthalate (DEP) in ratio 1 : 1 (w/w) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- From the beginning of treatment until 72 hours after treatment
- Number of animals:
- 4 rabbits, each was treated with 6 different concentrations of the test item
- Details on study design:
- TEST SITE
- Area of exposure: An area of 10 x 10 cm was clipped and divided into 6 test sites. Each test site was covered with a 2.5 x 2.5 cm gauze patch.
- % coverage: Not specified
- Type of wrap: The gauze patches were secured with 2.5 cm wide adhesive tape and fixed with Scanpor tape (5 cm width). Thereafter Nobifix (6 cm width) was loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, the treated skin was cleaned with lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
The skin reactions were read 1 hour after the end of treatment. Reading was also made 24, 48 and 72 hours after termination of exposure.
SCORING SYSTEM
- Method of calculation: The scores for erythema and oedema formation for the last 3 readings at 24, 48 and 72 hours for each rabbit were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation for the individual rabbits for each test concentration. The scoring system is described under "Any other information on materials and methods, incl. tables", table 1. - Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Remarks:
- The results are given for a 100 % test concentration. A test concentration of 25% showed an erythema score of 0.33 and 10%, 5% and 1% test concentrations showed a score of 0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not irritating to the skin.
- Executive summary:
The primary skin irritant effect of the test item was investigated in a GLP-compliant study according to the method recommended in OECD Guideline 404. The study was extended to investigate five different concentrations of the test article and a vehicle control on each animal. Four rabbits were exposed to different concentrations of the test article at six skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Under the experimental conditions described in this report, the mean score for erythema and oedema in the four rabbits used was as follows:
Test concentration
100%
25%
10%
5%
1%
Vehicle
Erythema
0.3
0
0
0
0
0
Oedema
0
0
0
0
0
0
The test item should thus not be classified as a skin irritant.
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
- Study period:
- 1998-09-07 to 1998-09-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992-12-29
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-2.3 kg
- Housing: Individually in PPO cages (floor area: 2576 cm^2) with perforated floor
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Undiluted - Duration of treatment / exposure:
- The substance remained in the eye throughout the whole study period (last reading 72 hours after beginning of treatment)
- Observation period (in vivo):
- 72 hours (1, 24, 48 and 72 hours after treatment)
- Number of animals or in vitro replicates:
- Four animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No washing was done
SCORING SYSTEM
See "Any other information on materials and methods, incl. tables" (table 1-3)
TOOL USED TO ASSESS SCORE: Fluorescein (24 hour reading), tool for other readings not specified - Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The score was 1 one hour after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour after application of the test article all animals showed some vessels definitely injected and swelling and discharge more than normal. After 24 hours there were no signs of irritation observed due to the test article in the eyes of all animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not irritating to the rabbit's eye.
- Executive summary:
The eye irritant effect of the test item was investigated in a GLP compliant study according to OECD guideline 405. Four female albino rabbits were exposed to 0.1 mL of the test item in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing. Very slight signs of irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:
Cornea opacity
Iris lesion
Redness of
conjunctiva
Oedema of
conjunctiva
Test item
0.0
0.0
0.0
0.0
According to Regulation (EC) No 1272/2008, the test item shall not be classified as eye irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation, rabbit, RL1
The primary skin irritant effect of the test item was investigated in a GLP-compliant study according to the method recommended in OECD Guideline 404. The study was extended to investigate five different concentrations of the test article and a vehicle control on each animal. Four rabbits were exposed to different concentrations of the test article at six skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Under the experimental conditions described in this report, the mean score for erythema and oedema in the four rabbits used was as follows:
Test concentration | 100% | 25% | 10% | 5% | 1% | Vehicle |
Erythema | 0.3 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
The test item should thus not be classified as a skin irritant.
Eye irritation, rabbit, RL1
The eye irritant effect of the test item was investigated in a GLP compliant study according to OECD guideline 405. Four female albino rabbits were exposed to 0.1 mL of the test item in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing. Very slight signs of irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:
| Cornea opacity | Iris lesion | Redness of conjunctiva | Oedema of conjunctiva |
Test item | 0.0 | 0.0 | 0.0 | 0.0 |
Based on the obtained results, the test item was considered not irritating to the eye.
Conclusion: The test item was not skin or eye irritating in vivo.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Thus, the test item is considered to be not classified for skin and eye irritation/corrosion under Regulation (EC) No 1272/2008, as amended for fifteenth time in Regulation (EU) No 2020/1182.
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