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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
According to EU Regulation (EC) N° 1272/2008 (CLP), the substance should be classified as a skin sensitizer, category 1B, as 50 % positive response were obtained with an intradermic induction dose of 1 % in the GPMT.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1A: GLP, OECD N°406 Guideline (1992, July 17th)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- date of study is before official adoption of LLNA guideline
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species and strain: Dunkin-Hartley guinea-pigs.
- 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 sensitizers.
- Breeder: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France.
- two males and two females for the preliminary test,
- Females were nulliparous and non-pregnant.
-Weight: on day 1, the animals of the main test were approximately 3 months old and bad a mean body weight ± standard deviation of 369 ± 24 g for the males and 362 ± 18 g for the females.
- Acclimatization: at least 5 days before the beginning of the study.
- Identification of the animals: ear-tattoo.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2°C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
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. - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5%
cutaneous induction: undiluted
cutaneous challenge: undiluted - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5%
cutaneous induction: undiluted
cutaneous challenge: undiluted - No. of animals per dose:
- Control group: 5 males and 5 females
Treated group: 10 males and 10 females - Details on study design:
-
MAIN STUDY
A. INDUCTION EXPOSURE
* Intradermal induction:
- On day 1, 3injections are realized on the scapular area:
- 0.1mL of Freund's complete adjuvant at 50% in 0.9% NaCl
- 0.1mL of the test item at 5 % (for treated group) or 0.1mL of vehicle (for control group)
- 0.1mL of a mixture 50/50 (V/V) of Freund's complete adjuvant in 0.9% NaCl and the test item at 5 % (for treated group) or the vehicle (for control group).
* Cutaneous induction:
- On day 7, local irritation is induced by application of Sodium Laurylsulfate 10% in Vaseline
- On day 8, occlusive application on the scapular area of 0.5mL of the test item 10% (for treated group) or vehicle (for control group) for 48 hours
B. CHALLENGE EXPOSURE D22
On day 22, 24hours occlusive application on the scapular area of 0.5mL of the undiluted test item on the right flank and 0.5mL of the vehicle on the left flank.
Reactions are evaluated 24 and 48 hours after removal of the dressing - Challenge controls:
- No
- Positive control substance(s):
- yes
- Remarks:
- Date-Study n°CIT/Study No. 17335 TSG; dinitrochlorobenzene
- Positive control results:
- Dinitro 2,4 Chlorobenzene : Positive result in recent study on ( ) females. Induction: test substance injected intradermally 0.05% (d1) and applied cutaneously 0.5% (d8). Challenge (d22): 0,1% r flank 0.5% l flank
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- score of more than 2 were considered positive
- 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: 20.0. Clinical observations: score of more than 2 were considered positive.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- only dryness of the skin was observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: only dryness of the skin was observed.
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under these experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance t-amy peroxyethyl-2-hexanoate induces delayed contact hypersensitivity in 9/20 (45%) guinea-pigs, with an intradermal induction dose of 5 % and undiluted substance for cutaneous application.
- Executive summary:
The delayed contact hypersensivity of t-amy peroxyethyl-2-hexanoate was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test) and in compliance with GLP.
The induction phase has been realized both by intradermal route on day 1 (5in vehicle) 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 the undiluted substance on the right flank (vehicle on the left flank); the cutaneous reactions were scored 24 and 48 hours after the challenge phase.
No cutaneous reactions were observed in the animals of the control group. In the treated group, at the 24-hour reading, a very slight (grade 1) or well-defined (grade 2) erythema was noted in 8/20 and 9/20 animals, respectively. No erythema persisted at the 48-hour reading. Dryness of the skin was observed in12/20 animals. The observed erythema with a score higher than 1 were considered as delayed contact hypersensitivity reactions.
In conclusion, the test item was considered as sensitizing in guinea pigs.
Reference
Individual scoring:
Group |
Sex |
Animal |
24h |
48h |
||||||
Erythema |
Oedema |
Erythema |
Oedema |
|||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
|||
Control |
M |
31 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
34 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
35 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Control |
F |
46 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
47 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
49 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Treated |
M |
36 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
37 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
38 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
39 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
40 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
41 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
42 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
43 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
44 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
45 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
|
||||||||||
Treated |
F |
51 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
52 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
53 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
54 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
55 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
56 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
57 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
58 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
59 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
60 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
LF=left flank
RF=right flank
A=crusts
S=dryness of the skin
No cutaneous reactions were observed in the animals of the control group.
In the treated group, at the 24-hour reading, a very slight (grade 1) or well-defined (grade 2)
erythema was noted in 8/20 and 9/20 animals, respectively.
No erythema persisted at the 48-hour reading. Dryness of the skin was observed in
12/20 animals.
The observed erythema with a score higher than 1 were considered as delayed contact hypersensitivity reactions.
no visible change.............................................................................................0
discrete or patchy erythema.............................................................................1
moderate and confluent erythema.....................................................................2
intense erythema..............................................................................................3
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
For this endpoint, a Klimisch 1study is available (Manciaux, 1999): the delayed contact hypersensivity of tert-amyl peroxyethyl-2-hexanoate was evaluated in guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test) and in compliance with GLP. The induction phase has been realized both by intradermal route on day 1 (5% in vehicle) 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 the undiluted substance on the right flank (vehicle on the left flank); the cutaneous reactions were scored 24 and 48 hours after the challenge phase. No cutaneous reactions were observed in the animals of the control group. In the treated group, at the 24-hour reading, a very slight (grade 1) or well-defined (grade 2) erythema was noted in 8/20 and 9/20 animals, respectively. No erythema persisted at the 48-hour reading. Dryness of the skin was observed in12/20 animals. The observed erythema with a score higher than 1 were considered as delayed contact hypersensitivity reactions.
In conclusion, the test item was considered as sensitizing in guinea pigs.
Migrated from Short description of key information:
Tert-amyl peroxyethyl-2-hexanoate induced skin sensitisation in a GPMT study (Manciaux, 1999). It is considered as a moderate skin sensitizer.
Justification for selection of skin sensitisation endpoint:
Key study, Klimisch 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no data regarding the sensitisation potential by inhalation route.
Justification for classification or non-classification
According to EU Regulation (EC) N° 1272/2008 (CLP), the substance should be classified as a skin sensitizer, category 1B, as 50 % positive response were obtained with an intradermic induction dose of 1 % in the GPMT.
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.
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