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EC number: 851-152-7 | CAS number: 1374570-57-6
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50 (rat) > 2000 mg/kg bw (OECD TG 420)
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:
- 16 November - 16 December 2021
- 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
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9-11 weeks old
- Weight at study initiation: 157 to 190 g
- Fasting period before study: Animals were fasted from the evening of the day prior to dosing to approximately three hours after dosing
- Housing: The animals were housed in groups of up to six in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific
Purposes’ (Home Office, London, 2014). Bedding was provided on a weekly basis to each cage by use of clean European soft wood bedding (Datesand Ltd., Manchester, UK). The bedding had been analysed for specific contaminants and the results retained on file at Labcorp. Each batch of bedding was analysed for specific constituents and contaminants. No contaminants were present in bedding at levels which might have interfered with achieving the objective of the study. Results are retained on file at Labcorp.
- Diet: 5LF2 EU Rodent Diet 14% was freely available to the animals at all times except during the fasting period
- Water: Mains water was provided ad libitum via water bottles
- Acclimation period: 7 to 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Target 19 to 25°C
- Humidity (%): Target 40 - 70 %, below target on two occasions at 21% and 24%,
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 November 2021 To: 16 December 2021 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL or 200 mg/mL
- Justification for choice of vehicle: The test article was dispersed in corn oil because the test article did not dissolve / suspend in purified water or 1% aqueous methylcellulose.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw - 1 female
2000 mg/kg bw - 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed at the beginning and the end of the working day for signs of ill health or overt toxicity.
- Body weights: Rats were weighed on Day-1 (day before dosing) and on Days 1, 4, 8 and 15
- Necropsy of survivors performed: yes
- Clinical signs: Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded, at approximately 15 and 30 minutes post-dose, hourly between 1
and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. - Preliminary study:
- The preliminary study was performed using one rat each at doses of 300 and 2000 mg/kg bw. Based on no mortality in the preliminary study a further group of 4 rats were dosed with 2000 mg/kg bw in the main study.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths seen at any dose level
- Clinical signs:
- other: Hunched posture, laboured breathing, decreased activity and ataxia were noted in one animal treated at 2000 mg/kg. These clinical signs developed from 2 hours after dosing and lasted up to 4 hours after dosing.
- Body weight:
- other body weight observations
- Remarks:
- All rats gained weight during the first and second weeks of the observation period
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- Category 5 based on GHS criteria
- Executive summary:
This study was conducted to assess the acute toxicity of the test article following a single oral administration to the rat.
In the preliminary study fasted female rats were given the test article as a single dose by oral gavage at dose levels of 300 and 2000 mg/kg. Since there were no deaths in the preliminary study, a further four fasted females were given a single oral dose of test article at a dose level of 2000 mg/kg.
The test article was dispersed in corn oil and administered at a dose volume of 10 mL/kg. All animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths. No clinical signs were seen in the animal treated at 300 mg/kg. Hunched posture, laboured breathing, decreased activity and ataxia were noted in one animal treated at 2000 mg/kg. These clinical signs developed from 2 hours after dosing and lasted up to 4 hours after dosing. All rats achieved body weight gains during the first and second weeks of the study. No abnormalities were noted at necropsy.
The test article was classified as Category 5 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and
Labelling of Chemicals (GHS).
Reference
Clinical Signs Following Treatment:
300 mg/kg bw: none
2000 mg/kg bw:
Animal number | Clinical sign | Sign Noted after Dosing on Day 1 (hours) |
Sign Noted on Day: | |||||||||||||
Imm | 1/4 | 1/2 | 1 | 2 | 3 | 4 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 - 15 | ||
883 | Hunched posture |
+ | + | + | ||||||||||||
Dyspnoea | + | |||||||||||||||
Decreased activity |
|
|
|
|
+ |
+ |
+ |
|
|
|
|
|
|
|
|
|
Ataxia |
|
|
|
|
+ |
+ |
|
|
|
|
|
|
|
|
|
Key:
Imm Immediately post-dose
+ Sign present (if no entry is made the sign is absent)
Clinical signs | Animal number | |||
884 | 885 | 886 | 887 | |
No observations | x | x | x | x |
Key:
x No clinical signs seen throughout the observation period
Individual Body Weights and Weekly Increments:
Dose
Level (mg/kg) |
Animal
Number
|
Body Weight (g) at:
|
Increment (g)
|
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 -8 |
Day 8 -15 |
||
300 |
882 |
183 |
170 |
190 |
195 |
203 |
25 |
8 |
2000
|
883 |
176 |
165 |
176 |
185 |
195 |
20 |
10 |
884 |
201 |
190 |
203 |
210 |
216 |
20 |
6 |
|
885 |
165 |
157 |
164 |
171 |
183 |
14 |
12 |
|
886 |
170 |
159 |
175 |
179 |
185 |
20 |
6 |
|
887 |
187 |
172 |
185 |
197 |
209 |
25 |
12 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
The acute oral toxicity of the test article in rats was assessed in a study performed according to OECD TG 420.
In the preliminary study fasted female rats were given the test article as a single dose by oral gavage at dose levels of 300 and 2000 mg/kg bw. Since there were no deaths in the preliminary study, a further four fasted females were given a single oral dose of test article at a dose level of 2000 mg/kg.
The test article was dispersed in corn oil and administered at a dose volume of 10 mL/kg. All animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths. No clinical signs were seen in the animal treated at 300 mg/kg. Hunched posture, laboured breathing, decreased activity and ataxia were noted in one animal treated at 2000 mg/kg. These clinical signs developed from 2 hours after dosing and lasted up to 4 hours after dosing. All rats achieved body weight gains during the first and second weeks of the study. No abnormalities were noted at necropsy.
The test article was classified as Category 5 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Justification for classification or non-classification
Acute oral toxicity: In a study using females rats performed according to OECD TG 420 the LD50 was > 2000 mg/kg bw. The substance is not classified under CLP.
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