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EC number: 840-202-3 | CAS number: 2101947-22-0
- 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 50-300 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 05 June 2018 and 03 July 2018.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliability 1 is assigned because the study conducted according to OECD TG 420 in compliance with GLP, without deviations that influence the quality of the results.
- 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 15-0735
Physical state / Appearance: Clear colorless liquid
Storage Conditions: Room temperature in the dark - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal Information
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:
- arachis oil
- Details on oral exposure:
- Test Item Preparation and Analysis
For the purpose of the study 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. - Doses:
- 300 mg/kg and 50 mg/kg
- No. of animals per sex per dose:
- 300 mg/kg: 5 females
50 mg/kg: 5 females - Control animals:
- no
- Details on 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 at 300 mg/kg.
In the absence of mortality at a dose level of 300 mg/kg, an additional group of 4 animals were treated.
A total of five animals were therefore treated at a dose level of 300 mg/kg in the study.
Due to mortality and signs of systemic toxicity at a dose level of 300 mg/kg, an additional animal was treated at 50 mg/kg.
In the absence of mortality at a dose level of 50 mg/kg, an additional group of 4 animals were treated.
A total of five animals were therefore treated at a dose level of 50 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 or at death.
At the end of the observation period the surviving 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:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 50 - <= 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg:
Four animals were killed for humane reasons during the day of dosing, due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office Project License.
50 mg/kg:
There were no deaths. - Clinical signs:
- other: 300 mg/kg: Signs of systemic toxicity commonly noted were hunched posture, ataxia and body tremors or occasional body tremors. Additional signs of systemic toxicity noted in three animals were vocalization, increased respiratory rate and increased activi
- Gross pathology:
- 300 mg/kg:
Patchy pallor of the liver was noted at necropsy of one animal. No abnormalities were noted at necropsy of the remaining three animals that were humanely killed during the study or the animal that was killed at the end of the study.
50 mg/kg:
No abnormalities were noted at necropsy. - Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral toxicity test showed an LD50 of between 50-300 mg/kg bw.
- Executive summary:
The study was performed to assess the acute oral toxicity of FRET 15 -0735 in the Wistar strain rat. Following a sighting test at a dose level of 300 mg/kg, a further group of four fasted females were given a single oral dose of test item, as a solution in arachis oil BP, at a dose level of 300 mg/kg body weight. Due to mortality and signs of systemic toxicity at a dose level of 300 mg/kg, an additional sighting test was performed at a dose level of 50 mg/kg. This was followed by a further group of four fasted females at a dose level of 50 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.The acute oral LD50 for the substance in female rats was determined to be between 50 -300 mg/kg bw.
Reference
Individual Clinical Observations and Mortality Data - 300 mg/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 |
0 |
HA |
HA |
HATo |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 |
VTRiIX* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
2-1 |
HToI |
HATo |
VTRiIX* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
2-2 |
HToA |
HATo (VCt)X* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
2-3 |
HToA |
HATo |
VTRiIX* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
0 = No signs of systemic toxicity H = Hunched posture A = Ataxia
T = Body tremors To = Occasional body tremors Ri = Increased respiratory rate
I = Increased activity V = Vocalization Ct = Tonic convulsions
X* = Animal killed for humane reasons due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office Project
Licence
- = No data, animal dead
() = Additional observations noted prior to being humanely killed
Individual Body Weights and Body Weight Changes - 300 mg/kg
Dose Level (mg/kg) |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight (g) |
Body Weight Gain (g) |
|||
0 |
7 |
14 |
1 |
2 |
|||
300 |
1-0 Female |
156 |
184 |
197 |
|
28 |
13 |
2-0 Female |
186 |
- |
- |
184 |
- |
- |
|
2-1 Female |
187 |
- |
- |
180 |
- |
- |
|
2-2 Female |
163 |
- |
- |
160 |
- |
- |
|
2-3 Female |
183 |
- |
- |
179 |
- |
- |
- = Animal dead
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 |
2-0 Female |
Humanely killed Day 1 |
No abnormalities detected |
|
2-1 Female |
Humanely killed Day 1 |
No abnormalities detected |
|
2-2 Female |
Humanely killed Day 1 |
No abnormalities detected |
|
2-3 Female |
Humanely killed Day 1 |
Liver: Patchy pallor |
Individual Clinical Observations and Mortality Data - 50 mg/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 |
||
50 |
3-0 |
0 |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 |
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 -50 mg/kg
Dose Level (mg/kg) |
Animal Number |
Body Weight (g) at Day |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
50 |
3-0 Female |
161 |
182 |
193 |
21 |
11 |
4-0 Female |
190 |
201 |
217 |
11 |
16 |
|
4-1 Female |
168 |
175 |
185 |
7 |
10 |
|
4-2 Female |
190 |
197 |
212 |
7 |
15 |
|
4-3 Female |
171 |
173 |
187 |
2 |
14 |
Individual Necropsy Findings -50 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
50 |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
4-0 Female |
Killed Day 14 |
No abnormalities detected |
|
4-1 Female |
Killed Day 14 |
No abnormalities detected |
|
4-2 Female |
Killed Day 14 |
No abnormalities detected |
|
4-3 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity:
The study was performed to assess the acute oral toxicity of FRET 15 -0735 in the Wistar strain rat.Following a sighting test at a dose level of 300 mg/kg, a further group of four fasted females were given a single oral dose of test item, as a solution in arachis oil BP, at a dose level of 300 mg/kg body weight. Due to mortality and signs of systemic toxicity at a dose level of 300 mg/kg, an additional sighting test was performed at a dose level of 50 mg/kg. This was followed by a further group of four fasted females at a dose level of 50 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.The acute oral LD50 for the substance in female rats was determined to be between 50-300 mg/kg bw.
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 is classified as acute toxic cat. 3 by the oral route.
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