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EC number: 482-070-6 | CAS number: 1001354-72-8
- 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
Acute oral toxicity study in the rat
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted OECD Guideline study conducted according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 175 mg/kg bw
550 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 175 mg/kg bw - 2 female;
550 mg/kg bw - 3 female;
2000 mg/kg bw - 1 female - Control animals:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 550 mg/kg bw
- Mortality:
- 550 mg/kg (3 animals):
2 animals died during the study (1 on day 0 and 1 on day 1)
2,000 mg/kg (1 animal):
This animal died within 2 hours of test substance administration. - Clinical signs:
- other: 175 mg/kg (2 animals): Both animals appeared active and healthy during the study - there were no adverse clinical signs, signs of gross toxicity or abnormal behaviour. 550 mg/kg (3 animals): Clinical signs noted prior to death included hypoactivity, pro
- Gross pathology:
- 175 mg/kg (2 animals):
There were no abnormalities noted at necropsy.
550 mg/kg (3 animals):
Gross necropsy of the decedents revealed discoloration of the intestines. No gross abnormalities were noted for the euthanized animal necropsied at the conclusion of the 14 -day observation period.
2,000 mg/kg (1 animal):
Clinical signs noted prior to death included hypoactivity, hunched posture and piloerection. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- XU-12314.00 appears to have moderate to low acute toxicity, with an LD50 of approximately 550 mg/kg.
- Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with Fischer 344 rats to determine the potential for XU-12314.00 to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of XU-12314.00 was estimated to be 550 mg/kg (the one dose with partial response) of body weight in female rats with a 95% PL confidence interval of 88.94 mg/kg (lower) to 2,430 mg/kg (upper).
Reference
Summary of results:
Animal number |
Sex |
Dose Level (mg/kg) |
Bodyweight (g) |
Dose 2 (ml) |
Mortality1 (day) |
||
Initial |
Day 7 |
Day 14 |
|||||
3101 |
F |
175 |
143 |
150 |
162 |
0.029 |
E |
3103 |
F |
130 |
137 |
149 |
0.026 |
E |
|
3102 |
F |
550 |
135 |
- |
- |
0.082 |
0 |
3104 |
F |
123 |
136 |
148 |
0.075 |
E |
|
3106 |
F |
130 |
- |
- |
0.079 |
1 |
|
3105 |
F |
2000 |
130 |
- |
- |
0.29 |
0 |
1 - E - Euthanized via CO2 inhalation after weighing on Day 14
2 - The test substance was administered as received. Specific Gravity – 0.897 g/mL.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 550 mg/kg bw
- Quality of whole database:
- good
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity of Octanolamine is relatively low, meeting the criteria for classification as Harmful (EU DSD) or Acute Toxicity class 4 (GHS). The oral administration of octanolamine appears to have resulted in the irritation of the gastrointestinal tract (evidenced by discoloration seen during necropsy). This irritancy appears to be due at least in part, to the high pH of the test substance once in solution (pH in excess of 11). Whether this was the cause or a contributing factor in the mortality observed at the mid and high doses is unclear.
Due to the Corrosive properties of octanolamine when applied to the skin it was not possible to conduct an acute dermal toxicity study. Therefore it is not possible to comment conclusively on whether this substance would be acutely toxic following exposure via the dermal route. However the corrosiveness of this substance will limit the potential for acute dermal exposure and thus toxicity in humans.
Due to the low vapour pressure of the material, the irritancy/corrosivity and the potential work place exposure scenarios it was not considered appropriate to conduct testing via the inhalation route.
Justification for selection of acute toxicity – oral endpoint
standard guideline study
Justification for selection of acute toxicity – inhalation endpoint
study waived due to low volatility and corrosivity.
Justification for selection of acute toxicity – dermal endpoint
study waived due to corrosivity
Justification for classification or non-classification
The substance has an acute oral LD50 of 550 mg/kg, this therefore requires classification as Harmful (EU DSD) and Toxic Class 4 (GHS).
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