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EC number: 210-596-6 | CAS number: 619-42-1
- 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:
- 2001-11-6 to 2002-2-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- Methyl 4-bromobenzoate
- EC Number:
- 210-596-6
- EC Name:
- Methyl 4-bromobenzoate
- Cas Number:
- 619-42-1
- Molecular formula:
- C8H7BrO2
- IUPAC Name:
- methyl 4-bromobenzoate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 051101-Sa
- Expiration date of the lot/batch: 2002-11-1
- Purity test date: 2001-11-12
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Hydrolysis is possible
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was supended in 0.1% CMC. The supensions were prepared freshly before administration and were administered within 10 minutes after the preparation.
- Final preparation of a solid: The test substance was supended in 0.1% CMC. The supensions were prepared freshly before administration and were administered within 10 minutes after the preparation.
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River WIGA, D-97633
- Age at study initiation: Approximately 8 weeks at the time of the administration
- Weight at study initiation: See Table 2
- Housing: Single cagin in Makrolon cages type III. Wire mesh lids. Sanitation of cages once a week
- Diet (e.g. ad libitum): Altromin 1324 forte, gamma irradiated with 25 kGy 60CO, ad libitum. Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterward. Random samples of the feed are analysed for contaminants by Altromin
- Water (e.g. ad libitum): Tap water from an automatic waterin system, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2
- Humidity (%): 47.7
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The tst substance was suspendet in 0.1% CMC
- Amount of vehicle (if gavage): The dose volume was 10 mL per kg body weight. The individual dose volumes were calculatet using the body weights determined on the day of the administration
- Lot/batch no. (if required): Article No. C-5013
MAXIMUM DOSE VOLUME APPLIED: The dose volume was 10 mL per kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was avaliable, a starting dose of 200 mg of the test substance per kg body weight was chosen. The further proceeding was in accordance with the guideline/directive - Doses:
- 200 mg per kg body weight to male rats
200 mg per kg body weight to female rats
2000 mg per kg body weight to male rats
2000 mg per kg body weight to female rats - No. of animals per sex per dose:
- 200 mg per kg body weight to male rats (3 animals)
200 mg per kg body weight to female rats (3 animals)
2000 mg per kg body weight to male rats (3 animals)
2000 mg per kg body weight to female (3 animals) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the scheduled termination of the study
- Clinical signs:
- other: The findings, with an onset shortly after the administration and lasting until a maximum of 6 h p.a. were: - central nervous effects: sedation This effect may also be due to discomfort. - Signs of discomfort: chromodacryorrhoea
- Gross pathology:
- The animals were killed by CO2 asphyxia 14 days p.a. and subjected to a necrospsy including a gross pathological examination.
Any other information on results incl. tables
Table1: Synopsis of the results
Dose (mg/kg) |
Sex |
Animal Nos. |
Number of animals Exposed affected deceased |
||
200 |
m |
11, 12, 13 |
3 |
0 |
0 |
200 |
f |
16, 17, 18 |
3 |
0 |
0 |
2000 |
m |
21, 22, 23 |
3 |
3 |
0 |
2000 |
f |
26, 27, 28 |
3 |
0 |
0 |
Table 2: Body weights and body weight gain.
Dose mg/kg Sex
|
Animal No. |
Body weight (g)
Before 7 days 14 days death administer p.a. p.a. |
Body weight gain (g)
0-7 days 7-14 days p.a. p.a. |
||||
200 m |
11 |
193 |
284 |
344 |
- |
91 |
60 |
12 |
205 |
296 |
365 |
- |
91 |
69 |
|
13 |
197 |
291 |
352 |
- |
94 |
61 |
|
mean SD |
198 6 |
290 6 |
354 11 |
- - |
92 2 |
63 5 |
|
200 f |
16 |
169 |
209 |
217 |
- |
40 |
8 |
17 |
165 |
205 |
223 |
- |
40 |
18 |
|
18 |
170 |
203 |
211 |
- |
33 |
8 |
|
mean SD |
168 3 |
206 3 |
217 6 |
- - |
38 4 |
11 6 |
|
2000 m |
21 |
204 |
300 |
365 |
- |
96 |
65 |
22 |
207 |
295 |
364 |
- |
88 |
69 |
|
23 |
207 |
284 |
343 |
- |
77 |
59 |
|
mean SD |
206 2 |
293 8 |
357 12 |
- - |
87 10 |
64 5 |
|
2000 f |
26 |
183 |
215 |
223 |
- |
32 |
8 |
27 |
166 |
206 |
219 |
- |
40 |
13 |
|
28 |
167 |
199 |
214 |
- |
32 |
15 |
|
mean SD |
172 10 |
207 8 |
219 5 |
- - |
35 5 |
12 4 |
Table 3: Observations in life.
Findings |
Dose mg/kg sex |
No. of the affected animals |
Observation time (p.a.) first last |
Maximum grade of severity |
Normal at any time |
200, m |
11, 12, 13 |
0h 14d |
- |
200, f |
16, 17, 18 |
0h 14d |
- |
|
2000, f |
26, 27, 28 |
0h 14d |
- |
|
chromodacryorrhoea |
2000, m |
21 |
4h 6h |
low |
sedation |
2000, m |
21 22 23 |
0,5h 4h 1h 2h 1h 2h |
low low low |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
This acute oral study is considered to be reliable. It does satisfy the guideline requirement for an acute oral study OECD 423 in the rat.
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