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EC number: 951-275-7 | 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: OECD TG 420: LD50 >2000 mg/kg bw.
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
- Study period:
- The study was conducted between 27 March 2018 and 25 April 2018.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Specific details on test material used for the study:
- Identification: FRET 14-0383
Physical state / Appearance: Clear colourless to very pale yellow liquid
Storage Conditions: 4 °C in the dark - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight of any previously treated animals.
Animal Care and Husbandry
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with wood flakes. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- other: 2000 mg/kg dose level: no vehicle, 300 mg/kg dose level: arachis oil BP
- Details on oral exposure:
- At 300 mg/kg
- Concentration in vehicle: 30 mg/mL
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): For the purpose of the 300 mg/kg dose level, the test item was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
CLASS METHOD (if applicable)
- In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
At 2000 mg/kg
MAXIMUM DOSE VOLUME APPLIED: 1.99 mL/kg
DOSAGE PREPARATION (if unusual): For the purpose of the 2000 mg/kg dose level, the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of mortality at a dose level of 300 mg/kg, an additional animal was treated at 2000 mg/kg dose level. - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 300 mg/ kg: 1 female treated per dose
2000 mg/kg: 1 female treated per dose
In the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals was treated: 4 females at 2000 mg/kg - Control animals:
- no
- Details on study design:
- Study Design
In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
A single animal was treated as follows:
Dose Level(mg/kg) Concentration(mg/mL) Dose Volume(mL/kg) Number of Rats(Female)
300 30 10 1
In the absence of mortality at a dose level of 300 mg/kg, an additional animal was treated as follows:
Dose Level(mg/kg) Specific Gravity Dose Volume(mL/kg) Number of Rats(Female)
2000 1.007 1.99 1
In the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose Level(mg/kg) Specific Gravity Dose Volume (mL/kg) Number of Rats(Female)
2000 1.007 1.99 4
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level - 300 mg/kg
There were no deaths.
Dose Level - 2000 mg/kg
There were no deaths. - Clinical signs:
- other: Dose Level - 300 mg/kg Signs of systemic toxicity noted up to 2 hours after dosing were tiptoe gait and/or hunched posture. The animal appeared normal 4 hours after dosing. Dose Level - 2000 mg/kg Hunched posture was noted in one animal during the day o
- Gross pathology:
- Dose Level - 300 mg/kg
No abnormalities were noted at necropsy.
Dose Level - 2000 mg/kg
No abnormalities were noted at necropsy. - Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity test for FRET 14-0383 showed an LD50 of >2000 mg/kg bw.
- Executive summary:
In this study, 1 female rat was administered the substance at dose levels of 300 mg/kg bw and 5 female rats were administered the substance at dose levels of 2000 mg/kg bw. The rats showed no mortality, body weight, necropsy at both dose levels. At 300 mg/kg, signs of systemic toxicity noted up to 2 hours after dosing were tiptoe gait and/or hunched posture. The animal appeared normal 4 hours after dosing. At 2000 mg/kg bw, hunched posture was noted in one animal during the day of dosing. The remaining four animals appeared normal throughout the observation period.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Unclassified).
Reference
Individual Clinical Observations and Mortality Data - 300mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1-0 |
HWt |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
H = Hunched posture
Wt = Tiptoe gait
Individual Body Weights and Body Weight Changes - 300mg/kg
Dose Level (mg/kg) |
Animal Number |
Body Weight (g) at Day |
Body Weight Gain (g) |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
1-0 Female |
159 |
176 |
207 |
17 |
31 |
Individual Necropsy Findings -300 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
Individual Clinical Observations and Mortality Data -2000mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
H = Hunched posture
Individual Body Weights and Body Weight Changes - 2000mg/kg
Dose Level (mg/kg) |
Animal Number |
Body Weight (g) at Day |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
184 |
195 |
206 |
11 |
11 |
3-0 Female |
195 |
202 |
207 |
7 |
5 |
|
3-1 Female |
180 |
184 |
197 |
4 |
13 |
|
3-2 Female |
206 |
207 |
221 |
1 |
14 |
|
3-3 Female |
206 |
220 |
231 |
14 |
11 |
Individual Necropsy Findings - 2000mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity:
In this study, 1 female rat was administered the substance at dose levels of 300 mg/kg bw and 5 female rats were administered the substance at dose levels of 2000 mg/kg bw. The rats showed no mortality, body weight, necropsy at both dose levels. At 300 mg/kg, signs of systemic toxicity noted up to 2 hours after dosing were tiptoe gait and/or hunched posture. The animal appeared normal 4 hours after dosing. At 2000 mg/kg bw, hunched posture was noted in one animal during the day of dosing. The remaining four animals appeared normal throughout the observation period.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Unclassified).
Justification for selection of acute toxicity – oral endpoint
The result of this study is reliable and adequate for covering this
endpoint.
Justification for classification or non-classification
According to the criteria outlined in Annex I of 67/548/EEC (DSD) and Annex VI of 1272/2008/EC (CLP), the substance does not have to be classified as acute toxic by the oral route.
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