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EC number: 200-915-7 | CAS number: 75-91-2
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Method equivalent to guideline study (except for skin abrasion) performed under GLP standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- stratum corneum penetrated by abrasion immediatelty prior to treatment
- Principles of method if other than guideline:
- Treatment sites abraded to penetrate straum corneum, but not dermis (and so as not to cause bleeding)
- GLP compliance:
- yes
- Test type:
- other: standard acute method but with skin abrasion
- Limit test:
- no
Test material
- Reference substance name:
- tert-butyl hydroperoxide
- EC Number:
- 200-915-7
- EC Name:
- tert-butyl hydroperoxide
- Cas Number:
- 75-91-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-methylpropane-2-peroxol
- Details on test material:
- Aqueous TBHP 70, 70 % tertiary butyl hydroperoxide
Lot number: A209413
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Langshaw farms, Augusta Michigan
- Weight at study initiation: 2.15 - 2.89 kg
- Housing: suspended stainless steel wire-bottomed cages
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow, 5322 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-32 days
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 240 sq. cm
- % coverage: 10%
- Type of wrap if used: Rubber latex dental dam secured with surgical porous tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Duration of exposure:
- 24 hours
- Doses:
- 0.5 mL/kg (480 mg/kg), 0.6 mL/kg (576 mg/kg), 0.75 mL/kg (720 mg/kg), 0.90 mL/kg (864 mg/kg), 1.30 mL/kg (1248 mg/kg), 2.08 mL/kg (1997 mg/kg).
- No. of animals per sex per dose:
- 10 rabbits per dose (5 male and 5 female).
For the 0.6 mL/kg dose level, only 9 rabbits (4 males; 5 females) were available.
For the 0.75 mL/kg and 0.90 mL/kg dose levels, only 6 rabbits (3 males; 3 females) were used. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosing and at least twice daily thereafter for a total of 14 days. Body weights were weighed at 0, 6 and 13 days.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 440 mg/kg bw
- Remarks on result:
- other: Adjusted for 70% TBHP content
- Mortality:
- Dosages expressed in terms of Aq. TBHP-70 test material.
At the 720 mg/kg dose level - 2 deaths occurred on day 0 and the rest died on day 1.
At 864 mg/kg and 1248 mg/kg dose levels - all animals died on day 1.
At the 1997 mg/kg dose level - 2 deaths at 2 hours post exposure, 2 deaths at 3 hours post exposure, 1 death at 4 hours post exposure, 3 deaths at 5 hours post exposure, 1 death at 6 hours post exposure. - Clinical signs:
- other: Dosages expressed in terms of Aq. TBHP-70 test material. No systemic toxicity observed at 480 mg/kg, 576 mg/kg, 864 mg/kg dose levels. At 720 mg/kg dose level, one animal appeared not to have use of its hindlimbs. At the 1248 mg/kg dose level, systemic si
- Gross pathology:
- Dosages expressed in terms of Aq. TBHP-70 test material.
480 mg/kg dose: Lungs pale in colour, but exuded foamy red material when sectioned. Liver surface appeared grained much like leather, bulged when sectioned and bled profusely and showed definite areas of pale yellow white and dark red, appeared to be acute congestion of the liver. In one rabbit, the spleen appeared to have dark red black areas that bulged on the surface of the upper half and flowed dark material when sectioned. In another rabbit, the spleen had multiple focal irregular pale areas. In one rat, the intestines was distended with gas.
576 mg/kg dose: no significant gross pathological findings.
720 mg/kg dose: In two animals the lungs were dark rose grey in colour. In another 3 animals, there was haemorrhage around the brain stem, red pink fluid in abdominal cavity, the urinary bladder contained dark red material, the peritoneal cavity was yellow gold in colour and lungs red tan in colour. In one rat, there was haemorrhage around the eyes, peritoneal cavity yellow gold in colour, liver chocolate in colour, lungs pinkish in colour.
864 mg/kg dose: In one rat, the intestines were pale and slight yellow in colour, the conjunctiva appeared slightly reddened and lungs were dark rose grey in colour.
1248 mg/kg dose: All animals displayed dark red brown lungs with marked autolysis.
1997 mg/kg dose: In five animals, the blood appears chocolate colour, body fat, tan to light brown in colour, lungs tan to chocolate in colour, spleen chocolate in colour and congested, liver chocolate in colour, leather grained surface and congested, kidneys chocolate and congested, spleen chocolate and congested, urinary bladder contracted to an almond size. In four animals, they displayed small urinary bladders which contained dark brown material.
Any other information on results incl. tables
An LD50 value of 628 mg/kg (95% confidence limits 559 to 705) is reported in this study.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This study shows that TBHP is harmful to rabbits via dermal exposure: LD50 value 440 mg/kg.
- Executive summary:
The study shows that TBHP is harmful to rabbits when given via the dermal route, with an acute LD50 value of 440 mg/kg. The results presented here corresponds to a classification of acute dermal toxicity category 3 under Regulation 1272/2008, CLP GHS.
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