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EC number: 202-532-0 | CAS number: 96-76-4
- 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:
- 01/02/1991-07/03/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study (OECD 401)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2,4-di-tert-butylphenol
- EC Number:
- 202-532-0
- EC Name:
- 2,4-di-tert-butylphenol
- Cas Number:
- 96-76-4
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2,4-di-tert-butylphenol
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Manston, Kent, U.K.
- Age at study initiation: approximately five to eight weeks old
- Weight at study initiation: At the start of the main study the males weighed 141 - 167 g, and females 139 - 151 g
- Fasting period before study: overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: the animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): with the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, food ad libitum (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, UK)
- Water (e.g. ad libitum): with the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, drinking water ad libitum
- Acclimation period: after minimum acclimatisation period of at least five days the animals selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 42-55%
- Air changes (per hr): approximately 15 changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: range-finding study: 500, 200, 20 mg/ml. main study: 200 mg/ml
- Dose volume 10 ml/kg. The volume administered to each animal was calculated according to its fasted bodyweight at time of dosing.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A range-finding study was performed using pre-selected dose levels to determine the highest of these dose levels that caused no deaths - Doses:
- Range-finding Study: 200, 2000 and 5000 mg/kg
Main Study: 2000 mg/kg - No. of animals per sex per dose:
- Range-finding Study: 3
Main Study: 5 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration:
Range-finding study: five days
Main study: 14 days
- Frequency of observations and weighing:
Range-finding study: 1/2, 1, 2, and 4 hours after dosing and then daily for five days. Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes.
Main study: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on the day of treatment (Day 0) and on Days 7 and 14
- Necropsy of survivors performed:
Range-finding study: no
Main study: yes, macroscopic observation
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Range-finding study: the female treated with 5000 mg/kg was found dead three days after treatment
Main study: no deaths - Clinical signs:
- other: Main study: no signs of systemic toxicity were noted during the study
- Gross pathology:
- Main study: no abnormalities were noted at necropsy (killed day 14)
Any other information on results incl. tables
Individual clinical observations and mortality data in the range finding study
Dose level Mg/kg |
Animal number & sex |
Effects noted after dosing (hours) |
Effects noted during period after dosing (days) |
|||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
||
5000 |
1-0 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 female |
0 |
0 |
0 |
0 |
0 |
LA |
X |
|||
2000 |
1-1 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-1 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
200 |
1-2 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Key:
L = lethargy
A = ataxia
X = animal dead
0 = no signs of systemic toxicity
Individual bodyweights and weekly bodyweight increases in the main study
Dose Level |
Animal Number |
Bodyweight (g) at Day | Increment (g) During Week | ||||
mg/kg | & Sex | 0 | 7 | 14 | 1 | 2 | |
2000 | 3 -0 Male | 141 | 198 | 250 | 57 | 52 | |
3 -1 Male | 167 | 216 | 275 | 49 | 59 | ||
3 -2 Male | 152 | 224 | 293 | 72 | 69 | ||
3 -3 Male | 144 | 214 | 267 | 70 | 53 | ||
2000 | 3 -4 Male | 143 | 206 | 272 | 63 | 66 | |
4 -0 Female | 151 | 192 | 220 | 41 | 28 | ||
4 -1 Female | 142 | 188 | 214 | 46 | 26 | ||
4 -2 Female | 140 | 178 | 206 | 38 | 28 | ||
4 -3 Female | 139 | 172 | 199 | 33 | 27 | ||
4 - 4 female | 139 | 185 | 212 | 46 | 27 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, DTBP, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material, DTBP, in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as Method B1 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 83/467/EEC).
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study.
All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material, DTBP, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labeling regulations.
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