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EC number: 247-955-1 | CAS number: 26748-41-4
- 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
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Endpoint summary
Administrative data
Description of key information
The test substance was tested in a MaximiyationTest according to OECD guideline 406. Taking into account the intensity of the responses and comparing theses with the skin reactions seen in the control animals, it was considered that hypersensitivity had been induced in nine (of the ten) experimental animals. The skin reactions as observed in the control animals were considered to be non-specific signs of irritation.These results indicate a sensitisation rate of 90 percent.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-12-07 to 2000-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate data from a guinea pig maximization test is available.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg Germany
- Age at study initiation: approx. 4 weeks old
- Weight at study initiation: individual body weights < 500 grams
- Housing: group housing of 5 animals per labelled metal cage with wire-mesh floors and equipped with an automatic drinking system
- Diet: free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg)
- Water: free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 30-70 %
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction (intradermal): 100 %
Induction (epicutaneous): 100 %
Challange (epicutaneous): 100 % - Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction (intradermal): 100 %
Induction (epicutaneous): 100 %
Challange (epicutaneous): 100 % - No. of animals per dose:
- Experimental group: 10 females
Control group: 5 females - Details on study design:
- RANGE FINDING TESTS: Practical feasibility of administration determined the highest starting-concentration for each route. The starting- and subsequent concentrations were taken from series: 100 % (undiluted), 50 %, 20 %, 10 %, 5 %, 2 %, 1 % and if needed, further lower concentrations using the same steps.
The test system and procedures were identical to those used during the main study, unless otherwise specified. The six animals selected were between 4 and 9 weeks old. No bdy weights were determined at termination.
MAIN STUDY
A. INDUCTION EXPOSURE
a) First induction (intradermal)
- No. of exposures: 1
- Exposure period: single treatment on day 1
- Test groups: A. A 1:1 w/w mixture of Freunds`Complete adjuvant with water for injection; B. The test substance at a 100 % concentration.; C. A 1:1 w/w mixture of the undiluted test substance and Freunds`Complete Adjuvant.
- Control group: treated with adjuvant and the vehicle
- Site: scapular region
- Frequency of applications: once
- Concentrations: 100 %
a) Second induction (epicutanous), 7 days after first induction
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: The scapular area was treated with 0.5 mL of a 100 % test substance concentration.
- Control group: treated with adjuvant and the vehicle
- Site: scapular region
- Frequency of applications: once
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 13 days after the epidermal exposure
- Exposure period: 24 hours
- Test groups: single treatment
- Control group: single treatment
- Site: flank
- Concentrations: 100 %
- Evaluation (hr after challenge): 24, 48 hours - Challenge controls:
- No
- Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamic aldehyde, tech. 85 %; Realiability check
- Positive control results:
- A reliability check is carried out at regular intervals to check the sensititivity of the test system and the reliability of the experimental techniques.
The skin reactions in eight experimental animals observed in response to the 10 % test substance concentration in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results lead to a sensitisation rate of 80 per cent to the 10 % concentration. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- other: not examined
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Taking into account the intensity of the responses and comparing theses with the skin reactions seen in the control animals, it was considered that hypersensitivity had been induced in nine (of the ten) experimental animals. The skin reactions as observed in the control animals were considered to be non-specific signs of irritation. These results indicate a sensitisation rate of 90 per cent.
- Executive summary:
Tert.butyl peroxyneodecanoate (75 % in solvent) was tested in a Maximisation Test in albino guinea pig according to EU method B.6 and OECD guideline no. 406. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with and epidermally exposed to a 100 % concentration. Five control animals were similarly treated, but with vehicle alone (water). Two weeks after the epidermal application all animals were challened with a 100 % test substance concentration and the vehicle.
In the challenge phase in response to the 100 % test substance concentration, skin reactions varying between grades 1 and 4 were observed in all experimental animals and skin reactions of grade 1 were observed in all control animals.
Eschar formulation was seen in the treated skin sites amoung the experimental animals.
Taking into account the intensity of the responses and comparing theses with the skin reactions seen in the control animals, it was considered that hypersensitivity had been induced in nine (of the ten) experimental animals. The skin reactions as observed in the control animals were considered to be non-specific signs of irritation. These results indicate a sensitisation rate of 90 per cent.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation
Tert-butyl peroxyneodecanoate (75 % in solvent) was tested in a Maximization Test in albino guinea pig according to EU method B.6 and OECD guideline no. 406. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten animals were intradermally injected with and epidermally exposed to a 100 % concentration. Five control animals were similarly treated, but with vehicle alone (water). Two weeks after the epidermal application all animals were challenged with the test substance and with the vehicle.
In response to the challenge treatment in the test group, skin reactions varying between grades 1 and 4 were observed in all test group animals and skin reactions of grade 1 were observed in all control group animals.
Eschar formulation was seen in the treated skin sites amoung the test group animals.
Taking into account the intensity of the responses and comparing it to the skin reactions observed in the control animals, it was considered that hypersensitivity had been induced in nine (of ten) test group animals. The skin reactions as observed in the control animals were considered to be non-specific signs of irritation. These results indicate a sensitisation rate of 90 per cent.
Tert-butyl peroxyneodecanoate (TBPND) was considered to have a sensitisation potential after it was examined in one skin senstisation study, a maximization method test in guinea pigs according to EU method B.6 and OECD guideline no. 406.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data the test item is classified and labelled as skin sensitising cat. 1 (H317: "may cause an allergic skin reaction") according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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.
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