Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-145-5 | CAS number: 63139-21-9
- 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:
- 2006-10-16 to 2007-08-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (4-ethylphenyl)boronic acid
- EC Number:
- 613-145-5
- Cas Number:
- 63139-21-9
- Molecular formula:
- C8 H11 B O2
- IUPAC Name:
- (4-ethylphenyl)boronic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: The mean initial body weight at the start of the study was 164 g (range from 156 to 175 g).
- Fasting period before study: Diet was withheld from 17 hours before until up to 4 hours after treatment.
- Housing: Separately in type III Makrolon cages, Conventional softwood granulate was used as the bedding.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 7 days before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 47 to 60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Methocel K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 15 g/L and 100 g/L
- Amount of vehicle: 20 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 20 mL of 100 g/L test item
CLASS METHOD
- Rationale for the selection of the starting dose: Limit dose - Doses:
- 2000 mg/kg bw and 300 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw: 3 males and 3 females
2000 mg/kg bw: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: Yes - Statistics:
- The body weight data were recorded with the PC-program "AKUDAT". The statistical evaluations of the body weight were carried out with the PC-program "TOX 511 A", developed by the Institute of Toxicology of Merck KGaA, Darmstadt. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement.
Results and discussion
- Preliminary study:
- Males treated with 2000 mg/kg bw. Signs of toxicity were seen immediately up to 6 hours after oral administration (locomotor disturbance, dyspnea).
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- 300 mg/kg bw: 0/3 males and 0/3 females;
2000 mg/kg bw: 3/3 females - Clinical signs:
- other: In rats treated with 2000 mg/kg, clinical signs were seen immediately up to 3 hours after oral administration. They consisted of salivation, abdominal position, locomotor disturbance, and dyspnea. Signs of toxicity were seen in the rats treated with 300 m
- Gross pathology:
- Gross pathology of two animals treated with 2000 mg/kg revealed in the stomach gas and fluid content. Histology examination revealed no corresponding changes. In all other animals that died or were sacrificed as planned, no macroscopic changes were detected.
Any other information on results incl. tables
Table 1: Mortality
Dose mg/kg bw |
Dead/ treated animals |
|
Males |
Females |
|
300 |
0/3 |
0/3 |
2000 |
- |
3/3 |
Table 2: Clinical findings (summary) for 300 mg/kg bw in male rats
Symptoms of intoxication at time after treatment |
Minutes |
Hours |
Day |
|||||||||||||||||||
1-15 |
15-60 |
1-2 |
2-3 |
3-4 |
4-5 |
5-6 |
6-24 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|
Sex: Male, Dose: 300 mg/kg bw |
||||||||||||||||||||||
Number of animals observed |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
Abdominal position |
/ |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Locomotor disturbance |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnea |
2 |
2 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No abnormal symptoms |
1 |
|
|
|
|
|
|
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
Sex: Male, Dose: 2000 mg/kg bw |
||||||||||||||||||||||
Number of animals observed |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
Table 3: Clinical findings (summary) for 300 mg/kg bw and 2000 mg/kg bw in female rats
Symptoms of intoxication at time after treatment |
Minutes |
Hours |
Day |
|||||||||||||||||||
1-15 |
15-60 |
1-2 |
2-3 |
3-4 |
4-5 |
5-6 |
6-24 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|
Sex: Female, Dose: 300 mg/kg bw |
||||||||||||||||||||||
Number of animals observed |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
No abnormal symptoms |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
Sex: Female, Dose: 2000 mg/kg bw |
||||||||||||||||||||||
Number of animals observed |
3 |
3 |
1 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salivation |
3 |
3 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal position |
3 |
3 |
1 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Locomotor disturbance |
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnea |
3 |
3 |
1 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 4: Body weights in grams (300 mg/kg bw, males and females)
|
|
|
Day |
|||||||
Dose |
Sex |
Animal No |
1 |
2 |
4 |
6 |
8 |
11 |
13 |
15 |
300 mg/kg bw |
Male
|
1 |
164 |
187 |
204 |
219 |
236 |
258 |
270 |
280 |
|
Male |
2 |
175 |
207 |
220 |
239 |
256 |
278 |
294 |
305 |
|
Male |
3 |
156 |
172 |
192 |
203 |
218 |
234 |
242 |
250 |
|
Female |
4 |
163 |
179 |
179 |
187 |
188 |
197 |
198 |
203 |
|
Female |
5 |
163 |
180 |
183 |
194 |
196 |
208 |
214 |
218 |
|
Female |
6 |
162 |
178 |
178 |
185 |
181 |
198 |
201 |
203 |
Table 5: Body weights in grams (2000 mg/kg bw, females)
|
|
|
Day |
|||||||
Dose |
Sex |
Animal No |
1 |
2 |
4 |
6 |
8 |
11 |
13 |
15 |
2000 mg/kg bw |
Female
|
7 |
160 |
|
|
|
|
|
|
|
|
Female |
8 |
161 |
|
|
|
|
|
|
|
|
Female |
9 |
170 |
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to the results of this study with the test item, the LD50 value is expected to be between 300 - 2000 mg/kg.
- Executive summary:
The test material was tested for acute toxicity in rats after single oral administration of 300 and 2000 mg/kg body weight. The test material was suspended with aqueous Methocel® K4M Premium solution as vehicle.This study was performed according to the "Acute toxic class method" (ATC) as described in the OECD Guideline 423. The rats treated with 300 mg/kg bw survived until the end of the observation period, whereas all rats treated with 2000 mg/kg bw died within 45 minutes and 3 hours after dosing. Signs of toxicity were seen in the rats treated with 300 mg/kg bw immediately up to 6 hours after oral administration. They consisted of locomotor disturbance, dyspnea and one female rat showed temporarily abdominal position. The body weight development of the rats was inconspicuous. In rats treated with 2000 mg/kg bw, clinical signs such as salivation, abdominal position, locomotor disturbance and dyspnea were seen immediately after oral administration. Gross pathology of two animals treated with 2000 mg/kg bw revealed gas and fluid content in the stomach. Histology examination revealed no corresponding changes. In all other animals that died or were sacrificed as planned no macroscopic changes were detected.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.