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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- 11 Feb - 22 Jun 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics
- Molecular formula:
- not applicable due to UVCB substance
- IUPAC Name:
- Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 169 - 198 g , weight variation did not exceed ± 20% of the mean weight
- Fasting period before study: overnight
- Housing: in groups of up to five per cage, clean European soft wood bedding (Datesand Ltd., Manchester, UK) was provided on a weekly basis
- Diet: 5LF2 EU Rodent Diet 14%, ad libitum
- Water: mains water via water bottles, ad libitum
- Acclimation period: 7 - 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 23 Feb 2021 To: 24 Mar 2021
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.32 mL/kg bw
DOSAGE PREPARATION: test substance was used undiluted, no dosage preparation was necessary - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female (300 mg/kg bw) and 5 females (2000 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed at the beginning and the end of the working day for signs of ill health or overt toxicity.
- Necropsy of survivors performed: yes; inspection of external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines
- Clinical signs were recorded immediately post-dose, at approx. 15 and 30 min post-dose, once per hour between 1 and 4 h post-dose, twice daily on Days 2, 3 and 4 and once daily from Day 5 to last day of the observation period, rats were weighed on the day before dosing)and on Days 1, 4, 8 and 15 (before necropsy).
Results and discussion
- Preliminary study:
- A preliminary test was performed to establish the dosing regimen for the main test. 1 female each was dosed at 300 and 2000 mg/kg bw. No mortality or adverse effects occurred and a dose level of 2000 mg/kb bw was selected for the main study.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until scheduled necropsy.
- Clinical signs:
- other: No clinical signs were recorded.
- Gross pathology:
- No abnormalities were noted at necropsy, except for abnormal shaped pituitary, pelvic dilatation and soft kidney, which were noted in a single animal dosed at 2000 mg/kg bw.
Any other information on results incl. tables
Table 1: Mortality Data
Dose Level (mg/kg bw) |
Mortality Ratio |
300 2000 |
0/1 0/5 |
Table 2: Clinical Signs Following Treatment
Dose Level (mg/kg bw) |
Clinical Sign |
Animal Number |
|||||
42 |
43 |
44 |
45 |
46 |
47 |
||
300 |
No observations |
ü |
- |
- |
- |
- |
- |
2000 |
No observations |
- |
ü |
ü |
ü |
ü |
ü |
Key: ü No clinical signs seen throughout the observation period
Table 3: Individual Body Weights and Weekly Increments
Dose Level (mg/kg bw) |
Animal Number |
Body Weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
300 |
42 |
181 |
169 |
184 |
194 |
204 |
25 |
10 |
2000 |
43 |
181 |
179 |
183 |
185 |
200 |
6 |
15 |
44 |
184 |
172 |
198 |
202 |
210 |
30 |
8 |
|
45 |
191 |
189 |
199 |
209 |
207 |
20 |
-2 |
|
46 |
205 |
198 |
219 |
223 |
226 |
25 |
3 |
|
47 |
184 |
176 |
192 |
194 |
235 |
18 |
41 |
A minus symbol [-] indicates a body weight loss
Table 4: Necropsy Findings
Dose Level: 300 mg/kg bw
Animal Number |
Time and Manner of Death (Day) |
Necropsy Comments |
42 |
15T |
No macroscopic changes |
Dose Level: 2000 mg/kg bw
Animal Number |
Time and Manner of Death (Day) |
Necropsy Comments |
43 |
15T |
No macroscopic changes |
44 |
15T |
Pituitary: Abnormal shape # Kidney: pelvic dilatation, right, moderate # |
45 |
15T |
No macroscopic changes |
46 |
15T |
No macroscopic changes |
47 |
15T |
No macroscopic changes |
T Animal killed by exsanguination under deep inhalation anaesthesia at completion of observation period
# Sample preserved in neutral buffered formalin
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- In this acute oral toxicity study in female rats a LD50 value of > 2000 mg/kg bw was determined.
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