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EC number: 271-272-8 | CAS number: 68527-63-9
- 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
- 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
Information from studies on skin sensitisation reveal skin sentsitising properties. Therefore, the substance is classified as a skin irritant, Skin Irrit. 2.
The substance was examined for eye irrittaing and eye damaging properties in a study according to OECD 492. The results do not allow a decision on C&L. For precautionary reasons the self-clasification is as Eye Damage. 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Information from study on acute dermal toxicity and skin sensitisation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Principles of method if other than guideline:
- The information gathered by the studies on acute dermal toxicity and skin sensitisation reveal skin irritating properties.
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- other: Information from studies on acute dermal toxicity and skin sensitisation
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- After Test ltem application, individual animals were frequently observed approximately at 30 minutes 1, 2, 3, 4, 5 and 6 hours post Test ltem application at day O (day of dosing) subsequently all animals were observed twice a day during the 14-day observation period, after dosing.
- Number of animals:
- 10
- Details on study design:
- Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (approximately 10 % body surface area) of rats was clipped by using clipper.
The Test ltem, dispensed under sterile conditions in sterilized glassware, was applied uniformly over clipped dorsal intact area of rat's trunk skin. Individual rat was applied the starting dose of 2000 mg/kg bw with a volume of Test ltem, calculated based on the latest body weight and Test ltem density (1.0124 g/ml) measured at the test facility.
Test ltem as such was held completely in contact with the skin with a porous gauze dressing (greater than 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. lt was ensured that the animals cannot ingest the Test ltem and rats were not immobilised. At the end of the exposure period, residual Test ltem was removed by using distilled water. - Irritation / corrosion parameter:
- other: Information from studies on skin sensitisation
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 10 animals (5 male, 5 female): 4 males and 4 females: score 2,0 1 male and 1 female: score 2,67
- Time point:
- 24/48/72 h
- Score:
- 2.13
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 10 animals (5 male, 5 female): 2 males and 2 females: score 2,0 3 males and 3 females: score 2,67
- Time point:
- 24/48/72 h
- Score:
- 2.4
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In an acute dermal toxicity study a single dose level of 2000 mg/kg of Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) was administered to Wistar rats (key study, see chapter 7.2.3 acute dermal toxicity). No signs of systemic toxicity were observed, indicating primarily a low dermal toxicity (the LD50 value of the test item is more than 2000 mg/kg body weight). But well defined erythema and slight oedema were observed in all the animals. At 48 & 72 hours observation the animals showed slight to well defined erythema, two animals showed moderate to severe erythema. Moderate oedema was also observed in six animals.
Information from this studies on acute dermal toxicity and skin sensitisation reveal skin irritating and skin sensitising properties. Therefore, the substance is classified as a skin irritant, Category 2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 2018-05-31 to 2018-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017-10-09
- Qualifier:
- according to guideline
- Guideline:
- other: 4.2.2 DB-ALM Protocol n° 190: SkinEthicTM HCE Eye Irritation Test Liquid (EITL)
- Version / remarks:
- 2017-06-07
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
R-127 / batch no. 180131
- Expiration date of the lot/batch:
2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Dry and dark at ambient temperature (10 – 30 °C)
- Stability under test conditions:
stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none - Species:
- human
- Strain:
- other: RhCE
- Details on test animals or tissues and environmental conditions:
- Test system: Reconstructed Human Corneal Epithelium, small, age day 5 (area: 0.5 cm2)
Source:
EPISKIN SNC
4, rue Alexander Fleming
69366 - Lyon Cedex 7
FRANCE - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
Application Substance Duration
Test substance 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item 30 ± 2 min
Negative contro 30 ± 2 µl 0.01M PBS pH = 7.4 30 ± 2 min
Positive control 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl methyl acetate 30 ± 2 min- Duration of treatment / exposure:
- Duration was 30 ± 2 min
- Duration of post- treatment incubation (in vitro):
- 37 ± 2 oC, 5 ± 1 % CO2, ≥ 90% humidity for 3 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- T1- (final), 30 min exposure
- Value:
- 26.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- T-2 (final) 30 min exposure
- Value:
- 19.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- Mean viablity both runs
- Value:
- 22.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is considered: No prediction can be made.
- Executive summary:
The substance Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) was examined for eye irrittaing and eye damaging properties in a study according to OECD 492.
The results do not allow a decision on C&L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Information from studies on acute dermal toxicity and on skin sensitisation reveal skin irritating and skin sensitising properties. Therefore, the substance is classified as a skin irritant, Skin Irrit. 2.
The substance was examined for eye irrittaing and eye damaging properties in a study according to OECD 492. The results do not allow a decision on C&L. For precautionary reasons the self-clasification is as Eye Irrit. 2.
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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