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EC number: 208-706-2 | CAS number: 538-93-2
- 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:
- October 2017 - November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate produced by "Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg"
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Isobutylbenzene
- EC Number:
- 208-706-2
- EC Name:
- Isobutylbenzene
- Cas Number:
- 538-93-2
- Molecular formula:
- C10H14
- IUPAC Name:
- (2-methylpropyl)benzene
- Test material form:
- liquid
- Details on test material:
- - batch no.: EXP-18/11/346
- State of aggregation: liquid
- Log KOW: 3.94 (calculated); 4.8 at 23°C and pH 6.0 (measured)
- Molecular weight: 134.22 g/mol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF; Batch identification: EXP-18/11/346
- Expiration date of the lot/batch: October 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed.
FORM AS APPLIED IN THE TEST: undiluted
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 188 g (mean); animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: October 24, 2017 To: November 21, 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.4 mL/kg body weight
time of day of administration: in the morning
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter; morbidity and mortality was checked at least once daily
- Frequency of weighing: shortly before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes, on the last day of the observation period
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- not observed
- Clinical signs:
- 1st test group:
- poor general state in 3/3 animals from day 1 to day 2
- piloerection in 3/3 animals from day 1 to day 2
- dyspneoa, cowering position and apathy in 2/3 animals on day 1
- exsiccosis in 2/3 animals from day 1 to day 2 or on day 1
- exophthalmos and staggering 1/3 animals on day 1
2nd test group:
- impaired up to poor general state in 3/3 animals from day 1 to day 3
- piloerection in 3/3 animals from day 1 to day 2 or 3
- cowering position in 3/3 animals on day 1
- non defecation, exsiccosis, apathy in 2/3 animals on day 1
- reduced defecation in 1/3 animals on day 1 - Body weight:
- 1st test group:
- stagnated or slightly decreased body weight in 2/3 animals during the 1st week (progression to normal weight gain during 2nd week)
- stagnated body weight in 1/3 animals during 2nd week
2nd test group: no effects observed - Gross pathology:
- no effects observed
Any other information on results incl. tables
Table 1: Mortality
Mortality |
||
Dose (mg/kg bw): |
2000 |
2000 |
Sex: |
female |
female |
Administration: |
1 |
2 |
No. of animals: |
3 |
3 |
Mortality (animals): |
No mortality |
No mortality |
Table 2: Individual body weight changes
Individual body weight changes |
||||||||||
Dose (mg/kg bw): |
2000 |
2000 |
||||||||
Administration: |
1 |
2 |
||||||||
Animal No.: |
R |
R |
R |
Mean weight |
Standard- deviation |
R |
R |
R |
Mean weight |
Standard- deviation |
645 |
646 |
647 |
671 |
672 |
673 |
|||||
Body weight at study day (g): |
|
|
|
|
|
|
|
|
|
|
0 |
191 |
195 |
203 |
196.3 |
6.11 |
181 |
179 |
179 |
179.7 |
1.15 |
7 |
- |
- |
- |
- |
- |
196 |
203 |
199 |
199.3 |
3.51 |
8* |
196 |
199 |
195 |
196.7 |
2.08 |
- |
- |
- |
- |
- |
14 |
199 |
207 |
206 |
204.0 |
4.36 |
204 |
211 |
210 |
208.3 |
3.79 |
*Due to a public holiday the body weight determination in the first test group was performed on study day 8.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of Isobutylbenzene after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, a dose of 2000 mg/kg bw of the undiluted test substance was administered by gavage to two test groups of three fasted Wistar rats each (6 females).
The following test substance-related clinical observations were recorded, clinical signs occurred within the first 3 days after administration:
2000 mg/kg (first test group):
- No mortality occurred
- Impaired general state in all animals
- Poor general state in one animal
- Dyspnoea in two animals
- Piloerection in all animals
- Exsiccosis in two animals
- Exophthalmos in one animal
- Cowering position in two animals
- Staggering in one animal
- Apathy in two animals
2000 mg/kg (second test group):
- No mortality occurred
- Impaired general state in all animals
- Poor general state in two animals
- Piloerection in all animals
- Exsiccosis in two animals
- Cowering position in all animals
- Apathy in two animals
- Reduced defecation in one animal
- Non defecation in two animals
The body weight of two animals in the first 2000 mg/kg bw test group stagnated or slightly decreased during the first week, but these animals gained weight in a normal range during the second week. The body weight of the third animal increased normally during the first week, but stagnated during the second week.
The body weight of the animals in the second 2000 mg/kg bw test group increased within the normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).
The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw
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