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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021/06/26 to 2022/01/20
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- EC Number:
- 271-272-8
- EC Name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- Cas Number:
- 68527-63-9
- Molecular formula:
- C22H42N2O.C4H10O4S
- IUPAC Name:
- 2-{2-[(8E)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol diethyl sulfate
- Test material form:
- liquid
- Details on test material:
- Test item formulations were found to be homogeneous and stable up to 24 hour in vehicle corn oil.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch number of test material: 10419
- Purity, including information on contaminants, isomers, etc.: 93 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Dry and dark at ambient room temperature (20 - 30 °C)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): test item was dispensed under sterile conditions in sterilized glassware
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In house bred at sa-FORD, Maharashtra, India.
CPCSEA Registration 1256/PO/RcBi/S/09/CPCSEA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation:
male: minimum: 226 g, maximum 232 g
female: minimum 205 g, maximum 210 g
- Fasting period before study: no
- Housing: all animals were housed individually in polycarbonate cages provided with sterilized corn cobs (M/S. Krishna Corncob Industries- Aurangabad) Batch No.: 221
- Diet (e.g. ad libitum): all animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum, Batch No.: 040521
- Water (e.g. ad libitum): aqua guard filtered tap water was provided ad libitum via drinking bottles. Samples of drinking water was tested to microbial tests and chemical contaminant analysis on twice in year.
- Acclimation period: all animals were acclimatized to the test conditions for 7 days prior to the application of the test item
ENVIRONMENTAL CONDITIONS
- Temperature (°C): min.21.2 °C; max. 22.7 °C
- Humidity (%): min. 53.1 %; max. 62.9 %
- Air changes (per hr): more than 12
- Photoperiod (hrs dark / hrs light): 12 hrs dark and 12 hrs light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped dorsal intact area of rat's trunk skin
- % coverage: 10
- Type of wrap if used: porous gauze dressing (greater than 10% of body surface area of rat) and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, by distilled water
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
male: 0.45/0.46 ml
female: 0.4/0.41 ml
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five male and five female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
After Test Item application, individual animals were frequently observed approximately at 30 minutes 1, 2, 3, 4, 5 and 6 hours post test item application at day 0 (day of dosing) subsequently all animals were observed twice a day during the 14-day observation period, after dosing. Animals were observed twice daily for any mortality and morbidity during the experimental period. After removal of the patch, all animals were examined for signs of erythema and oedema as per Draize Criteria (Refer Appendix 1) and scored at 24, 48 and 72 hours post dosing.
All rats were weighed on test days 0 (prior to application), 7 and 14.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- No statistical analysis was performed for LD50 calculation since the study was terminated with limit test.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality and morbidity were observed at limit dose of 2000 mg/kg body weight of test item during the 14 days observation period.
Any other information on results incl. tables
- of erythema formation for animal no. 01, 02, 03, 04, 05, 06, 07, 08, 09 and 10 at treated sites were 2.00, 2.00, 2.00, 2.00, 2.67, 2.00, 2.67, 2.00, 2.00, 2.00
- and for oedema 2.67, 2.67, 2.67, 2.00, 2.00, 2.67, 2.00, 2.00, 2.67 and 2.67 respectively
Clinical observation
No systemic reactions of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period.
Skin Reaction
Well defined erythema and slight oedema (edges of area well defined by definite raising) were observed in all the animals (animal no. 1 to 10). At 48 & 72 hours observation in animal number 01, 02, 03, 06, 09 and 10 well defined erythema and moderate oedema was observed and animal number 04, 08 showed well defined erythema and slight oedema whereas animal number 05 and 07 showed moderate to severe erythema & slight oedema.
The individual mean score (at 24, 48 and 72 hours)
Mortality and morbidity
No mortality and morbidity were observed at limit dose of 2000 mg/kg body weight of test item during the 14 days observation period.
Body weight
The body weight of the animals was within the range of commonly recorded for this strain and age. All rats showed a normal increase in their body weights during the 14 days observation period when compared to day 0.
Pathology
External Observation
The external observation of all terminally sacrificed animals did not show any pathological abnormality.
Internal observation
The internal observation of all terminally sacrificed animals did not show any pathological abnormality.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study the acute dermal toxicity LD50 value Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) in Wistar rats was estimated as being greater than 2000 mg/kg body weight in male and female Wistar rats.
Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) is classified as follows:
- "Category 5/ Unclassifed" (the dermal LD50 range of 2000 to 5000 mg/kg bw) as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS); as there were no mortalities observed at 2000 mg/kg body weight.
- "Category 4" (the dermal LD50 range of 1000 < ATE 2000 mg/kg bw) as per Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. - Executive summary:
The acute dermal toxicity study of Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro1 H-imidazole-1-ethanol (1:1) in Wistar Rats, was performed as per the OECD Guideline No. OECD No. 402 and EU Method B.3.
A starting dose of 2000 mg/kg body weight (bw) based on the test item density (1.0124 g/mL) was applied based on latest body weight of individual animal weight by single dermal application and observed for 14 days after dermal treatment.
No mortality was observed in any animal till the end of the experimental period.
At 2000 mg/kg body weight, all animals were normal throughout the experimental period. Therefore, the test was terminated with a limit test at 2000 mg/kg body weight. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
Under the conditions of this study the acute dermal toxicity LD50 value of Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro1 H-imidazole-1-ethanol (1:1) in Wistar rats was estimated as being greater than 2000 mg/kg body weight in male and female Wistar rats.
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