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Diss Factsheets
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EC number: 268-732-5 | CAS number: 68134-15-6
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-01-29 to 1992-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
- Molecular formula:
- not available for UVCB
- IUPAC Name:
- Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 5 - 8 weeks old
- Weight at study initiation: males: 126 - 140 g; females: 126 - 134 g
- Fasting period before study: Yes
- Housing: In groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 53 - 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
- Doses:
- 2000 mg/kg bw (Dose volume: 1.74 ml/kg bw)
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, other toxicological effects
Results and discussion
- Preliminary study:
- There were no deaths or clinical signs of toxicity. The results of the range-finding study indicated that the acute oral median lethal dose of the test item was greater than 2000 mg/kg bw. Based on this information, a dose level of 2000 mg/kg bw was selected for the main study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- Individual clinical observations and mortality data are given in section "Any other information on results incl. tables"
- Body weight:
- All animals showed expected gain in bodyweight during the study.
- Gross pathology:
- No abnormalities were noted at necroscopy.
- Other findings:
- None
Any other information on results incl. tables
Table: Individual clinical observations and mortality data in the main study
Dose Level mg/kg bw |
Animal Number & Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
1/2 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2000 | 3-0 Male |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3-1 Male |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-2 Male |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-3 Male |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-4 Male |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-0 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-1 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-2 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-3 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-4 Female |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 = No signs of systemic toxicity
Table 2: Individual bodyweights and weekly bodyweight gain in the main study
Dose Level mg/kg |
Animal Number & Sex |
Bodyweight (g) at Day | Bodyweight Gain (g) | During Week | ||
0 | 7 | 14 | 1 | 2 | ||
2000 | 3-0 Male | 137 | 216 | 270 | 79 | 54 |
3-1 Male | 134 | 202 | 254 | 68 | 52 | |
3-2 Male | 132 | 209 | 267 | 77 | 58 | |
3-3 Male | 140 | 209 | 261 | 69 | 52 | |
3-4 Male | 126 | 194 | 254 | 68 | 60 | |
4-0 Female | 129 | 170 | 197 | 41 | 27 | |
4-1 Female | 126 | 174 | 206 | 48 | 32 | |
4-2 Female | 127 | 164 | 197 | 37 | 33 | |
4-3 Female | 134 | 187 | 221 | 53 | 34 | |
4-4 Female | 128 | 169 | 186 | 41 | 17 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item in the Spraque-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test item in the Spraque-Dawley strain rat according to OECD Guideline 401 and in compliance with GLP principles. Following a range finding study, a group of ten fasted animals, five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bw. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination. In result, there were no deaths. No signs of toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. Thus, the LD50 of the test item was determined to be greater than 2000 mg/kg bw. The test is regared to be valid.
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