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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
Endpoint summary
Administrative data
Description of key information
The substance was found to be not sensitizing in guinea pigs. The key study was a guinea pig optimization test in which none of the 20 animals showed skin reactions after the challenge reaction.
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:
- 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.
- 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
- 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 - Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1%
- 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
- Positive control results:
- Positive controls were not reported.
- 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
- 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
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Experimental data regarding skin sensitization is available from three reports, all of them pre-dating GLP requirements. The key study was chosen because it is the only one which is adequate in design and reporting. Limitations are that positive control data not included in the report and that the dose selection was not justified. The test is an optimization test in guinea pigs performed with a suspension of 0.1% in propylene glycol. As the test item is of overall solubility, the chosen dose was probably the highest that could be injected. In 1980, another study in guinea pig with a similar design was performed, however due to the low number of animals, it is of limited value for hazard assessment. A report on a human patch test with 50 volunteers is available. No incidence of skin reactions was reported. Overall, the substance is concluded to be non-sensitizing. Absence of findings in animal studies is consistent with the very high molecular weight of 1178 Da of the test substance. Such substances are too large to penetrate the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.
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