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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-687-3 | CAS number: 686-31-7
- 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
Tert-amyl peroxy-2-ethylhexanoate is not irritating for rabbit eye and skin (Reagan, 1981).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2a Guideline study without detailed documentations (no certificat of analysis for example)
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.4l.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: purchased from H.A.R.E. - Rabbits for Research, Hewitt, N.J. for use in this study.
- Age at study initiation: no data
- Weight at study initiation: 2-4 kg
- Housing :individually in wire mesh bottom cages in an environment-controlled room.
- Diet and water : ad libitum
- Acclimation period: quarantined for a minimum of 5 day
ENVIRONMENTAL CONDITIONS
All housing and care conformed to the sta'ndards established in "Guide for the Care and use of Laboratory Animals" DHEW publication
No. (NIH) 78-23. - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved or abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 or 72 hours
- Number of animals:
- 6
- Details on study design:
- Shortly before dosing, the dorsal surface of each rabbit was clipped free of fur with electric clippers.
During this procedure, care was taken to avoid accidential abrasion to the skin.
Just prior to test article application, the test site on the right dorsal side was abraded with the tip of a 22 gauge hypodermic needle. The abrasions were 4 incisions made in cross hatch which penetrated the stratum corneum but did not disturb the derma and/or produce bleeding. - Irritation parameter:
- other: erythema and edema scores
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Max. score:
- 0
- Remarks on result:
- other: shaved skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After a 24-hour exposure period under occlusive conditions, tert-amyl peroctoacte is not irritating for rabbit skin.
- Executive summary:
The acute dermal irritation of tert-amylperoctoate was evaluated in rabbits according to 16 CFR 1500.4l. guideline and in compliance with GLP. The test item was applied undiluted to the skin of 3 New Zealand White rabbits (shave skin or abraded skin) and held in contact for 24 hours by means of an occlusive dressing.
Mean scores over 24, and 72 hours for each animal were for erythema and eschar foramation, and for edema.
On shaved skin, no irritation was observed (all scores were 0). On abraded skin, slight to moderate signs of irritation were observed but only at 24 hours, not at 72 hours.
Under the experimental conditions, after a 24-hour exposure period under occlusive conditions, tert-amyl peroctoacte is not irritating for rabbit skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Scores:
Exposure time (h) | Skin | Rabbit 1 | Rabbit 2 | Rabbit 3 | Rabbit 4 | Rabbit 5 | Rabbit 6 | |
Erythema and eschar formation | 24 | intact | 2 | 2 | 2 | 1 | 1 | 1 |
72 | intact | 0 | 0 | 0 | 0 | 0 | 0 | |
24 | abraded | 2 | 2 | 2 | 1 | 1 | 1 | |
72 | abraded | 0 | 0 | 0 | 0 | 0 | 0 | |
Edema formation | 24 | intact | 0 | 1 | 1 | 0 | 0 | 1 |
72 | intact | 0 | 0 | 0 | 0 | 0 | 0 | |
24 | abraded | 0 | 1 | 1 | 0 | 0 | 1 | |
72 | abraded | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2a Guideline study without detailed documentations (no certificat of analysis for example)
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 1500
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: purchased from H.A.R.E. - Rabbits for Research, Hewitt, N.J. for use in this study.
- Age at study initiation: no data
- Weight at study initiation: 2-4 kg
- Housing :individually in wire mesh bottom cages in an environment-controlled room.
- Diet and water : ad libitum
- Acclimation period: quarantined for a minimum of 5 day
ENVIRONMENTAL CONDITIONS
All housing and care conformed to the sta'ndards established in "Guide for the Care and use of Laboratory Animals" DHEW publication
No. (NIH) 78-23. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Prior to the test, the eyes were examined with sodium fluorescein and an ultraviolet lamp. only animals without any lesion were used for the test.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these experimental conditions, tert-amyl peroxyoctoacte is not irritating for rabbit eye.
- Executive summary:
The potential of tert-amyl peroxyoctoacte to induce ocular irritation was evaluated in rabbits according to CFR 1500 guideline and in compliance with GLP.
A single dose of 0.1mL of the undiluted test item was administered to one eye of six New Zealand White Rabbits.
. The other eye was not treated and served as control.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.
Mean scores for all animals over 24, 48 and 72 hours were 0 for chemosis, redness of the conjunctiva, iris lesions and for corneal opacity.
Under these experimental conditions, tert-amyl peroxyoctoacte is not irritating for rabbit eye.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two well conducted study are avaible. Both were Klimisch 2, GLP compliant.
The acute dermal irritation of tert-amylperoctoate was evaluated in rabbits according to 16 CFR 1500.4 guideline and in compliance with GLP (Reagan, 1981). The test item was applied undiluted to the skin of 3 New Zealand White rabbits (shave skin or abraded skin) and held in contact for 24 hours by means of an occlusive dressing. Mean scores over 24, and 72 hours for each animal were for erythema and eschar formation, and for edema. No irritation was observed on shaved skin (all scores were 0).
The eye irritation potential was evaluated in rabbits according to CFR 1500 guideline and in compliance with GLP. A single dose of 0.1mL of the undiluted test item was administered to one eye of six New Zealand White Rabbits. The other eye was not treated and served as control. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. Mean scores for all animals over 24, 48 and 72 hours were 0 for chemosis, redness of the conjunctiva, iris lesions and for corneal opacity. Therefore tert-amyl peroxy-2-ethylhexanoate is not irritating for rabbit eye.
Justification for selection of skin irritation / corrosion
endpoint:
Key study, Klimisch 2.
Justification for selection of eye irritation endpoint:
Key study, Klimisch 2.
Justification for classification or non-classification
According to the directive 67/548/EEC and according to EU Regulation (EC) N0. 1272/2008 (CLP), tert-amyl peroxy-2 -ethylhexanoate is not a skin or an eye irritant.
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.