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EC number: 219-552-0 | CAS number: 2460-77-7
- 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
The purpose of the study was to evaluate the potential toxic effect of the Test Item 2,5-Di-tert-butyl- 1,4-benzoquinone when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the Test Item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose.
At the dose of 2000 mg/kg bw signs of toxicity was observed on Day 2 after administration. On Day 5 two animals were found dead. One died on Day 3. On Day 6 the rest of the animals were sacrificed due to ethical reasons. At dose of 300 mg/kg bw no mortalities were found.
At dose of 2000 mg/kg bw four animals were sleepy and lethargic. On Day 3 and after mild tremor and hyperaemia of eyes, ears and mouth were observed in all animals. At dose of 300 mg/kg bw animals were lethargic from Day 1 to Day 6. On the subsequent days, negative reactions were not registered.
Body weights were reduced in the group of 2000 mg/kg bw, at week 1 (three animals ). No body weigh changes were observed in the group of 300 mg/kg bw.
To examine gross pathology in the animals of 2000 mg/kg bw group animals 1-3 could not be necropsied because of cadavers were autolyzed. Animals 4-6 were found to have pronounced hyperaemia of extremities, ears, eyes and mouth and hypertrophy of both adrenals (diameter about 5-7 mm) was recorded. In animals of 300 mg/kg bw group no findings macroscopic findings at necropsy.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the 2,5-Di-tert-butyl-1,4-benzoquinone is classified in Category 4 with a LD50 cut off value 500 mg/kg body weight, after single oral administration to Wistar rats.
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:
- 6 July 2016 to 19 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Lot/batch no. (if required): L52897
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information on similar tested compounds indicate that the test item is likely to be nontoxic considering acute toxicity. - Doses:
- 300 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6+6 (all females)
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose of 2000 mg/kg bw signs of toxicity was observed on Day 2 after administration. On Day 5 two animals were found dead. One died on Day 3. On Day 6 the rest of the animals were sacrificed due to ethical reasons.
At dose of 300 mg/kg bw no mortalities were found. - Clinical signs:
- other: At dose of 2000 mg/kg bw four animals were sleepy and lethargic. On Day 3 and after mild tremor and hyperaemia of eyes, ears and mouth were observed in all animals. At dose of 300 mg/kg bw animals were lethargic from Day 1 to Day 6. On the subsequent day
- Gross pathology:
- 2000 mg/kg bw group: Animals 1-3 could not be necropsied because of cadavers were autolyzed. Animals 4-6 were found to have pronounced hyperaemia of extremities, ears, eyes and mouth and hypertrophy of both adrenals (diameter about 5-7 mm) was recorded.
300 mg/kg bw group: no findings macroscopic findings at necropsy. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test Item 2,5-Di-tert-butyl-1,4-benzoquinone is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test Item 2,5-Di-tert-butyl-1,4-benzoquinone is classified in Category 4 with a LD50 cut off value 500 mg/kg body weight, after single oral administration to Wistar rats.
- Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the Test Item 2,5-Di-tert-butyl- 1,4-benzoquinone when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the Test Item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose. Test item-related mortality was observed on Day 5 and Day 7 after administration. In the third step another 3 females were treated at the dose of 300 mg/kg body weight. All females survived 24 hours and 14-day observation period. Due to the delayed toxic effects of the Test Item, other females (fourth step) were treated 14 days after the first administration of the dose 300 mg/kg body weight. Toxicity sings were observed in females treated with the dose of 2000 mg/kg body weight on Day 2 after administration of the Test Item. Animals from the first group (No 1-3) were sleepy and lethargic. From Day 3 mild tremor and the hyperaemia of the eyes, ears and mouth were observed in all animals too. This behaviour was observed also next days. On Day 5 after administration of the test item,
animals No 2 and 3 were found dead. Female No 1 died on Day 7. Animals died probably during the night hours, their cadavers were found in a state of autolysis. Similar signs were observed in the same time period after test item administration in animals No 4-6. Animals No 1-3 could not be necropsied because their cadavers were autolysed. Due to ethical reasons, on Day 6, animals No 4-6 were sacrificed and were subjected to gross necropsy. Pronounced
hyperaemia of extremities, ears, eyes and mouth and hypertrophy of both adrenals (diameter about 5-7 mm) were recorded. No mortality was observed in females treated with the Test Item at the dose of 300 mg/kg body
weight. Animals were lethargic from Day 1 to the Day 6. On the subsequent days, negative reactions were not registered. Body weight losses or stagnation of body weight were observed after week 1 after administration of the Test Item. Between week 1and week 2 no body weight losses were registered in 5 females; in one female mild body weight decrease was registered during necropsy, no macroscopically findings were noticed. The LD50 of the Test Item 2,5-Di-tert-butyl-1,4-benzoquinone is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the Test Item 2,5-Di-tert-butyl-1,4-benzoquinone is classified in Category 4 with a LD50 cut off value 500 mg/kg body weight, after single oral administration to Wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Reliable without restrictions.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the criteria in CLP Annex I, 2,5-Di-tert-butyl-1,4-benzoquinone is classified in Category 4 with a LD50 cut off value 500 mg/kg body weight.
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