Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 252-029-5 | CAS number: 34443-12-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the implementation of the REACH regulation
Test material
- Reference substance name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- EC Number:
- 252-029-5
- EC Name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- Cas Number:
- 34443-12-4
- Molecular formula:
- C13H26O4
- IUPAC Name:
- 3-({[(tert-butylperoxy)carbonyl]oxy}methyl)heptane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The choice of the vehicle was based on tests to check the homogeneity (visual check) of the preparation (for cutaneous application and intradermal injections) and its free passage through a needle (for intradermal injections). The highest concentrations which satisfied these criteria were called the maximal practicable concentrations.The vehicle used was corn oil.
Strain and sanitary status: Hartley Crl: (HA) BR, Caesarian obtained, Barrier sustained - Virus; Antibody Free (COBS- VAF@)
Reason for this choice: species generally accepted by regulatory authorities for this type of study. The strain used has been shown to produce a satisfactory sensitization response using known positive sensitizers.
Breeder: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France.
Main test: 30 animals (15 males and 15 females) for the main test. Females were nulliparous and non-pregnant.
Weight: on day 1, the animals of the main test were approximately 3 months old and had a mean body weight ±standard deviation of 358 ± 10 g for the males and 362 ± 14 g for the females. Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: ear-tattoo.
Environmental conditions:
. temperature: 21 ± 2°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
Food and water ad libitum. No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 10%
- Day(s)/duration:
- D1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- D8
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- D22
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- D33
- No. of animals per dose:
- 5 males and 5 females
Control group : 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS:
Preliminary test: one male and one female.
By intradermal route:
24 hours before treatment, the dorsal region of the animals was clipped,
intradermal administrations of the test substance formulation (0.1 ml) at different concentrations were performed in the interscapular region, cutaneous reactions were evaluated approximately 24, 48 hours and 6 days after the injections
By cutaneous route:
24 hours before treatment, both flank regions of the animals were clipped, a volume of 0.5 ml of the undiluted test substance or test substance formulation at the chosen concentration(s) was placed on a dry gauze pad (approximately 4 cm2 which was then applied to the skin and held in place by an occlusive dressing for 24 hours, cutaneous reactions were evaluated approximately 24 and 48 hours after removal of the dressings
MAIN STUDY
Induction by intradermal route:
Three injections of 0.1 ml were made into each side of this interscapular region (i.e. three pairs of sites), as follows:
Injection sites Treated group Control group
Anterior 1: FCA diluted at 50% (v/v) with 0.9% NaCl 1: FCA diluted at 50% (v/v) with 0.9% NaCl
Middle 2: test substance at 10% (w/w) in corn oil 2: vehicle
Posterior* 3: test substance at 10% (w/w) in a mixture FCA /0.9% NaCI 50/50 (v/v) 3: vehicle at 50% (w/w) in a mixture FCA /0.9% NaCl
50150 (v/v)
Induction by topical administration:
As the test substance was shown to be non-irritant during the preliminary test, the animals were treated at day 7 with 0.5 ml of sodium lauryl sulfate at the concentration of 10% (w/w) in vaseline, in order to induce local irritation.
Duration exposure for topical application: 48 hours, occlusive dressing
Challenge:
Topical application, duration exposure: 24 hours, occusive dressing - Positive control substance(s):
- yes
- Remarks:
- DNCB (CIT/Study No. 17335 TSG) - September 1998
Results and discussion
- Positive control results:
- According to the Magnusson and Kligman method, the test substance DNCB at the concentration of 1 % (w/w) induced positive skin sensitization
reactions in 90% guinea-pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TBEC was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
- Executive summary:
The delayed contact hypersensivity of TBEC was evaluated in Guinea pigs according to OECD N°406 guideline (July 17th1992 - Magnusson and Kligman test). The induction phase has been realized both by intradermal route on day 1, at the concentration of 10 % in corn oil
and by cutaneous route on day 8 (undiluted) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 22 by cutaneous application of TBEC (50% in corn oil); the cutaneous reactions were scored 24 and 48 hours after the challenge phase. As equivocal cutaneous reactions were noted, a second challenge application was perforrned under the same experimental conditions after a rest period of 10 days, except that the test substance and the vehicle were applied to the left and right flanks, respectively. At the end of the study, animals were killed and skin samples were taken from the challenge application sites of all the animals showing skin reactions. An histological examination was performed on the preserved tissue samples. After the first challenge application, at the 24-hour reading, a very slight erythema was observed in 4/10 animals of the control group and in 8/20 animals of the treated group. A well-defined erythema was noted in 1/10 animals of the control group and in 4/20 animals of the treated group. Most of these cutaneous reactions, associated with dryness of the skin, persisted at the 48-hour reading. A well-defined erythema was also recorded on the left control flank of 1/20 animals of the treated group.After the second challenge application, at the 24-hour reading, a very slight erythema was still observed in 3/10 animals of the control group and in 8/20 animals of the treated group. A well-defined erythema was noted in 1/10 animals of the control group (but was already noted before the second challenge application) and in 5/20 animals of the treated group. A few cutaneous reactions, associated with dryness of the skin, persisted at the 48-hour reading. As the cutaneous reactions observed in the animals of the treated group after both challenge applications were of similar incidence and severity when compared to those recorded in the animals of the control group, they were attributed to irritant properties of the test substance but not to delayed contact hypersensitivity. This was supported by the fact that most of the observed cutaneous reactions decreased between the 24-hour reading and the 48-hour reading and by the absence of any observed oedema. Histhological examinations confirmed that TBEC was not sensitizing to guinea pig skin. In conclusion, under these experimental conditions, TBEC was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.