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EC number: 223-356-0 | CAS number: 3851-87-4
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation was assessed in a primary dermal irritation study (TNO, 1976) and an in vitro skin corrosion test according to OECD 431
Eye irritation was assessed similar to OECD 405 (TNO, 1976)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012-03-20 to 2012-03-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Valid without restriction; GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: reconstituted three-dimensional human skin model EpiDerm (MatTek)
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Test system:
The test was carried out with the reconstituted three-dimensional human skin model EpiDermTM (MatTek). It consists of non-cancerous, human-derived epidermal keratinocytes (NHEK) which have been cultutred to form a multi-layered, highly differentiated model of the human epidermis. The NHEK are cultured are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The test systewm exhibits in vivo like morphological and growth characteristics and consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo. - Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: EpiDerm Tissue was treated with distilled water and 8 N KOH
- Amount / concentration applied:
- The test item was applied undiluted. 50 µl of the test item were dispensed directly onto the EpiDerm tissue. The test item was spread to match size of the tissue.
- Duration of treatment / exposure:
- 3 minutes and 60 minutes exposure
- Observation period:
- n.a.
- Number of animals:
- n.a.
- Details on study design:
- see "any other information on materials and methods incl. tables"
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 90
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 83
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects:
- n.a.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study the test item Peroxan NPO is not considered to be corrosive.
- Executive summary:
The potential of the test item to induce skin corrosion was analysed by using the three dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum. Peroxan NPO was applied topically to the EpiDerm tissue for 3 min and 60 min, respectively followed by immediate determination of cytotoxic effects via MTT reduction assay.
The test item showed no corrosive potential. The mean relative tissue viability (% negative control) was >= 50% (90%) after 3 min treatment and >= 15% (83%) after 60 min treatment.
The controls confirmed the validity of the study. The mean OD550 of the two negative control tissues was >= 0.8 for each exposure period. The mean relative tissue viability of the positive control was =< (14%) after 3 min treatment. The maximum inter tissue difference of replicate tissues of all dose groups was =< 30 % (0.1%-21.7%).
Reference
Table1: 3 min Exposure
Name |
Negative Control |
Test item |
Positive control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD550-Werte |
2.080 |
2.087 |
1.959 |
1.787 |
0.309 |
0.269 |
2.082 |
2.088 |
1.962 |
1.784 |
0.315 |
0.271 |
|
2.068 |
2.061 |
1.945 |
1.770 |
0.312 |
0.269 |
|
Mean OD550 |
2.077 |
2.079 |
1.955 |
1.780 |
0.312 |
0.270 |
SD |
0.008 |
0.015 |
0.009 |
0.009 |
0.003 |
0.001 |
Total mean OD550(mean of two replicate tissues) |
2.078* |
1.868 |
0.291 |
|||
Mean relative tissue viability [%] |
100 |
90 |
14** |
|||
Mean inter tissue viability difference [%]*** |
0.1 |
9.4 |
14.5 |
* mean OD550 ≥ 0.8
** mean relative tissue viability of the 3 min positive control ≤ 30 %
*** inter tissue viability difference ≤ 30 %
Table 2: 60 min Exposure
Name |
Negative Control |
Test item |
Positive control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD550-Werte |
1.955 |
1.763 |
1.815 |
1.454 |
0.114 |
0.119 |
1.983 |
1.790 |
1.692 |
1.376 |
0.117 |
0.129 |
|
2.000 |
1.782 |
1.706 |
1.361 |
0.115 |
0.121 |
|
Mean OD550 |
1.979 |
1.778 |
1.706 |
1.361 |
0.115 |
0.121 |
SD |
0.023 |
0.014 |
0.067 |
0.050 |
0.002 |
0.005 |
Total mean OD550(mean of two replicate tissues) |
1.879* |
1.567 |
0.119 |
|||
Mean relative tissue viability [%] |
100 |
83 |
6 |
|||
Mean inter tissue viability difference [%]*** |
10.7 |
21.7 |
6.4 |
* mean OD550 ≥ 0.8
*** inter tissue viability difference ≤ 30 %
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restriction
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : no clinical observation after 1 h
- Principles of method if other than guideline:
- The techniques of tests as published by the FDA of the US (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) are followed
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- no hay or other extrageneous material that might enter the eye
- examination of of the eyes before testing - Vehicle:
- unchanged (no vehicle)
- Remarks:
- 75% solution in isododecane
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): 75% solution in isododecane - Duration of treatment / exposure:
- as long as observation period; the eyes were not washed after treatment
- Observation period (in vivo):
- observation after 24 h, 48 h and 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: FDA scoring scale (equivalent to Draize (1944))
TOOL USED TO ASSESS SCORE: binocular - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye lesions caused by Trigonox 36-CD 75 are below the threshold of classification according to regulation No. 1272/2008.
- Executive summary:
In a primary eye irritation study 100 µl of Trigonox 36-CD 75 (Bis(3,5,5 -trimethylhexanoyl)peroxide) was instilled into the everted lower lid of one eye of 6 New Zealand White albino rabbits. The eyes were not washed after instillation. Animals were observed after 24, 48 and 72 hours. Irritation was scored according the FDA scoring scale. The eye lesions were of moderate degree after 24h.and completely reversible within 72h. After 24 hours an average score of 1.67 of conjunctivae redness and an average score 2.3 of conjunctivae chemosis was observed. The mean values of the 24-48-72h readings were below the threshold of classification according to regulation No. 1272/2008 (CLP).
Reference
Table 1: Individual scores awarded to the ocular lesions elicited by Trigonox 36-CD 75
Rabbit number |
Cornea |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
||||
After 24 hours |
|||||
25 |
1 |
0 |
2 |
2 |
|
26 |
0 |
0 |
2 |
3 |
|
27 |
0 |
0 |
1 |
2 |
|
28 |
0 |
0 |
2 |
2 |
|
29 |
0 |
0 |
2 |
3 |
|
30 |
0 |
0 |
1 |
2 |
|
After 48 hours |
|||||
25 |
0 |
0 |
1 |
0 |
|
26 |
0 |
0 |
1 |
0 |
|
27 |
0 |
0 |
1 |
0 |
|
28 |
0 |
0 |
1 |
0 |
|
29 |
0 |
0 |
1 |
0 |
|
30 |
0 |
0 |
0 |
0 |
|
After 72 hours |
|||||
25 |
0 |
0 |
0 |
0 |
|
26 |
0 |
0 |
0 |
0 |
|
27 |
0 |
0 |
0 |
0 |
|
28 |
0 |
0 |
0 |
0 |
|
29 |
0 |
0 |
0 |
0 |
|
30 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation was assessed in a primary dermal irritation study (TNO, 1976). Severe erythema to slight eschar formation was observed 24 h and 72 h after exposure on intact as well as on abraded skin. Very slight to slight edemas were observed on intact as well on abraded skin after 24 h and 72 h. Because the reversibility of the adverse effects had not been assessed after 14 days the study does not allow to conclude on potentially irreversible effects. Thus, an in vitro skin corrosion test according to OECD 431 was conducted to exclude corrosivity. The test item was found not to be corrosive.
Eye irritation was assessed in a primary eye irritation study (TNO, 1976). Eye lesions were of moderate degree after 24h.and completely reversible within 72h. The mean values of the 24-48-72h readings were below the threshold of classification according to regulation No. 1272/2008 (CLP).
Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study
Justification for selection of eye irritation endpoint:
comparable to guideline study
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The test item is a skin irritant according to CLP, but not corrosive (Skin Irrit 2).
A classification as eye irritant has not been warranted. Conjunctivae effects were observed during the first 48h of the experiment not leading to classification according to regulation No. 1272/2008 (CLP).
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