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EC number: 230-907-9 | CAS number: 7365-45-9
- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
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- 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 vivo (OECD TG 404): not irritating (reference 7.3.1 -1).
Eye irritation in vivo (OECD TG 405): not irritating (reference 7.3.2 -1).
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:
- October 01, 2002 - May 19,2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- yes
- Remarks:
- The body weight at the start of the study was outside the target range of 2.50-5.50 kg. This deviation did not influence the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: ~15 weeks
- Weight at study initiation: 2.05 kg (range from 2.00 to 2.13)
- Housing: separately in special rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 19
- Humidity (%): 45 to 72
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: day 1 To: day 8 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test material mixed with some drops of Aqua pro injectione to ensure good contact
- Duration of treatment / exposure:
- 4 hour period under semiocclusive conditions
- Observation period:
- 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100 %
- Type of wrap: Fixomull® stretch, Beiersdorf
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Draize (1959) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed at the treated areas.
- Other effects:
- - Other adverse systemic effects: No signs of clinical toxicity were detected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected. The test material can be regarded as non irritant.
- Executive summary:
The test performed in accordance with OECD TG 404. 0.5 g of the test material mixed with some drops aqua pro injectione were spread onto 6 cm² patches and applied to the intact skin of 3 previously shaven rabbits (females) for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
Under the conditions of the present study, no signs of toxicity were seen.
Evaluation of each animal:
Mean score (24h, 48h, 72h)
Maximum value (24h, 48h, or, 72h)
Animal No.
31
32
33
31
32
33
Erythema
0.0
0.0
0.0
0
0
0
Edema
0.0
0.0
0.0
0
0
0
No skin irritating potential could be detected. The test material should 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:
- October 01, 2002 - May 19, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24th, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.65 kg (range from 2.51 to 2.75)
- Housing: kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20
- Humidity (%): 42 - 58
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: day 1 To: day 8 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 30 s
- Observation period (in vivo):
- 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope - 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
- 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 #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 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 #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- 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
- 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
- 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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 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
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Redness of the conjunctivae and discharge were regarded as slight transient signs of mechanical irritation. The test material should not be regarded as an irritant for the eyes.
- Executive summary:
- The primary eye irritation was assessed in accordance with OECD TG 405. For the test of primary eye irritation, 0.1 g of the test material was applied into the conjunctival sac of rabbits. The study was started as an initial test with 1 animal and followed by the confirmatory test with 2 further animals.
No signs of irritation could be observed at the cornea or iris. The conjunctivae showed redness (score 1) at the first (1 hour) and second (24 hours) reading. Chemosis (score 1) was seen in the first reading. Furthermore discharge (score 1 and 2) at the first reading was observed. Thereafter no signs of irritation were observed. The untreated eyes were unchanged.
Mean score
(24h, 48h, 72h)
Maximum value
(24h, 48h or 72h)
Animal No.
34
32
39
34
32
39
Cornea
0.00
0.00
0.00
0
0
0
Iris
0.00
0.00
0.00
0
0
0
Conjunctivae (Redness)
0.33
0.33
0.00
1
1
0
Conjunctivae (Chemosis)
0.00
0.00
0.00
0
0
0
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One GLP compliant study to assess skin irritation/corrosion potential and one GLP-compliant study to assess eye irritation potential of 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid have been performed.
Skin irritation
The test was performed in accordance with OECD TG 404 (reference 7.3.1 -1). The test material was applied to the intact skin of 3 previously shaven rabbits (females) for a 4 hours period under semi-occlusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days. Under the conditions of the present study, no signs of toxicity were seen (erythema score (24/48/72h):0; edema score (24/48/72h): 0). No skin irritating potential could be detected. The test material should not be classified as a skin irritant.
Eye irritation
The test was performed in accordance with OECD TG 405 (reference 7.3.2 -1). For the test of primary eye irritation, 0.1 g of the test material was applied into the conjunctival sac of rabbits. The study was started as an initial test with 1 animal and followed by the confirmatory test with 2 further animals. No signs of irritation could be observed at the cornea or iris. The conjunctivae showed redness (score 1) at the first (1 hour) and second (24 hours) reading. Chemosis (score 1) was seen in the first reading. Furthermore discharge (score 1 and 2) at the first reading was observed. Thereafter, no signs of irritation were observed. The untreated eyes were unchanged. Redness of the conjunctivae and discharge were regarded as slight transient signs of mechanical irritation. The test material should not be regarded as an irritant to the eyes.
Justification for classification or non-classification
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for eye and skin irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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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