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Registration Dossier
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EC number: 229-722-6 | CAS number: 6683-19-8
- 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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The test performed is rather insensitive, since injection of propylene glycol results in necrosis, which gives a high background level of reaction volume. Positive control data not included in the report. Dose selection not justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 10 h light instead of 12 h. The adjuvant was used during the 2nd and 3rd week. Age of the animals unknown. missing initial individual body weights.
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- A valid in vivo study is available, therefore no LLNA has been performed
Test material
- Reference substance name:
- Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
- EC Number:
- 229-722-6
- EC Name:
- Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
- Cas Number:
- 6683-19-8
- Molecular formula:
- C73H108O12
- IUPAC Name:
- 3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Bred on the premises
- Weight at study initiation: 400 - 450 g
- Housing: Individually in Macrolon cages type 3,
- Diet (e.g. ad libitum): Ad libitum, NAFAG, No. 830, Gossau SG
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1%
Challenge
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 (intradermal injections, every second day except week-ends)
- Exposure period: 3 w
- Site: Right flank and back
- Frequency of applications: every second day (except weekends)
- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 14 after the last induction (intradermal challenge) and 10 after the first challenge (epicutaneous challenge)
- Exposure period: 11 d and 24 h
- Site: Left flank
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24 - Challenge controls:
- Vehicle and 5 % in vaseline
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Positive controls were not reported.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group intradermal challenge
- Dose level:
- 0.1 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: negative control group intradermal challenge
- Dose level:
- Vehicle
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: test group epicutaneous challenge
- Dose level:
- subirritant dose
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: negative control epicutaneous challenge
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
Any other information on results incl. tables
Table 1. Reaction volumes (μL) after intradermal injection of propylene glycol (vehicle).
Animal No | Induction | After skin sensitization | Positive reactor (+) | |||||||
Application No |
Mean (x‾) | Standard deviation(s) | (x‾-s) |
|||||||
1 | 2 | 3 | 4 | |||||||
♂ | 1 | 12 | 24 | 120 | 50 | 51 | 48 | 99 | 158 | + |
2 | 88 | 81 | 30 | 45 | 61 | 28 | 89 | 28 | - | |
3 | 60 | 88 | 200 | 80 | 107 | 63 | 170 | 25 | - | |
4 | 32 | 77 | 106 | 52 | 67 | 32 | 99 | 110 | + | |
5 | 73 | 196 | 160 | 80 | 127 | 60 | 187 | 292 | + | |
6 | 30 | 204 | 30 | 80 | 86 | 82 | 168 | 60 | - | |
7 | 64 | 71 | 100 | 70 | 76 | 16 | 92 | 100 | + | |
8 | 12 | 220 | 115 | 0 | 87 | 103 | 190 | 15 | - | |
9 | 22 | 15 | 140 | 110 | 72 | 63 | 135 | 88 | - | |
10 | 25 | 270 | 112 | 72 | 120 | 106 | 226 | 192 | - | |
♀ | 11 | 32 | 84 | 0 | 70 | 47 | 38 | 85 | 36 | - |
12 | 231 | 53 | 120 | 96 | 125 | 76 | 201 | 22 | - | |
13 | 5 | 21 | 90 | 160 | 69 | 71 | 140 | 60 | - | |
14 | 67 | 120 | 40 | 52 | 70 | 35 | 105 | 144 | + | |
15 | 32 | 252 | 120 | 130 | 134 | 90 | 224 | 202 | - | |
16 | 100 | 34 | 120 | 72 | 82 | 37 | 119 | 15 | - | |
17 | 45 | 11 | 245 | 140 | 110 | 105 | 215 | 70 | - | |
18 | 134 | 204 | 80 | 260 | 170 | 79 | 249 | 36 | - | |
19 | 156 | 34 | 100 | 220 | 128 | 79 | 207 | 96 | - | |
20 | 72 | 14 | 38 | 43 | 42 | 24 | 66 | 22 | - | |
Group mean | 65 | 104 | 103 | 94 | 88 | 5/20 |
Table 2. Reaction volumes (μL) after intradermal injection of test material (0.1 %).
Animal No | Induction | After skin sensitization | Positive reactor (+) | |||||||
Application No | Mean (x‾) | Standard deviation (s) | (x‾-s) | |||||||
1 | 2 | 3 | 4 | |||||||
♂ | 1 | 79 | 92 | 54 | 120 | 86 | 27 | 113 | 187 | + |
2 | 154 | 132 | 70 | 104 | 115 | 36 | 151 | 63 | - | |
3 | 66 | 70 | 99 | 86 | 80 | 15 | 95 | 64 | - | |
4 | 121 | 158 | 58 | 88 | 106 | 43 | 149 | 90 | - | |
5 | 90 | 70 | 99 | 83 | 85 | 12 | 97 | 265 | + | |
6 | 73 | 70 | 36 | 22 | 50 | 25 | 75 | 240 | + | |
7 | 254 | 204 | 108 | 14 | 145 | 106 | 251 | 235 | - | |
8 | 117 | 132 | 97 | 48 | 98 | 37 | 135 | 44 | - | |
9 | 88 | 110 | 150 | 108 | 114 | 26 | 140 | 139 | - | |
10 | 43 | 157 | 88 | 102 | 97 | 47 | 144 | 176 | + | |
♀ | 11 | 96 | 143 | 49 | 121 | 102 | 40 | 142 | 109 | - |
12 | 216 | 437 | 43 | 22 | 179 | 192 | 371 | 101 | - | |
13 | 108 | 130 | 64 | 62 | 91 | 34 | 125 | 250 | + | |
14 | 154 | 72 | 72 | 88 | 96 | 39 | 131 | 35 | - | |
15 | 200 | 132 | 63 | 134 | 132 | 56 | 188 | 77 | - | |
16 | 130 | 181 | 104 | 150 | 141 | 32 | 173 | 108 | - | |
17 | 145 | 136 | 44 | 88 | 103 | 47 | 150 | 150 | - | |
18 | 121 | 104 | 63 | 62 | 87 | 30 | 117 | 72 | - | |
19 | 145 | 132 | 42 | 56 | 94 | 52 | 146 | 99 | - | |
20 | 160 | 151 | 84 | 144 | 135 | 34 | 169 | 22 | - | |
Group mean | 128 | 141 | 74 | 85 | 126 | 5/20 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs
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