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EC number: 940-417-3 | CAS number: -
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 November 2011-22 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well-performed study; Guideline study; GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, 80538 München, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species/strain: healthy CBA/CaOlaHsD mice
Source: Harlan Winkelmann, 33178 Borchen, Germany
Sex: female (nulliparous and non-pregnant)
Age at the
beginning of the study: 8 – 9 weeks
Full barrier in an air-conditioned room
Temperature: 22 ± 3 °C
Relative humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice (preliminary test: lot no. 1956, main study: lot no. 0815)
Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding (preliminary test: lot no. 19072011, main study: lot no. 11082011)
Certificates of food, water and bedding are filed at BSL BIOSERVICE
Adequate acclimatisation period (at least five days) under laboratory conditions - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100%, undiluted test item
50% and 25%, diluted with acetone/olive oil - No. of animals per dose:
- 5,
3 animals for the preliminary test - Details on study design:
- Preparation of the Animals:
The animals were randomly selected.
Identification was ensured by cage number and individual marking (tail).
Clinical Observation:
Prior to the application and once a day thereafter all animals were observed in order to detect signs of toxicity, including dermal irritation at site of application.
Weight Assessment:
The animals were weighed prior to the application and at the end of the test period (prior to the treatment with 3HTdR).
Dose Groups:
3 test groups (3 different concentrations) and 1 negative control group (vehicle) were tested.
Test Regime:
Topical Application
Each mouse was treated by topical application of 25 µL of the selected solution to the entire dorsal surface of each ear.
Topical applications were performed once daily over three consecutive days.
Administration of 3H-Methyl Thymidine
Five days after the first topical application all mice were dosed with 20 µCi 3H-methyl thymidine by intravenous injection (tail vein) of 250µL of 3H-methyl thymidine, diluted to a working concentration of 80µCi/mL.
Preparation of Cell Suspension
Approximately 5 hours after the injection of 3H-methyl thymidine all mice were sacrificed by cervical dislocation. The draining “auricular lymph nodes” were excised, individually pooled for each animal (2 lymph nodes per animal) and collected in phosphate buffered saline (PBS). A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze (200 mesh size). After washing the gauze with PBS the cell suspension was pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure was repeated.
After the final wash each pellet was resuspended in approx. 1 mL 5% TCA at approx. 4° C for approximately 18 hours for precipitation of macromolecules. Each precipitate was once washed again, resuspended in 1 mL 5% TCA and 7 mL scintillation fluid was added. Then this solution was transferred into scintillation vials and stored at room temperature overnight.
Determination of Incorporated 3H -Methyl Thymidine
The 3H-methyl thymidine – incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Similarly, background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually for each animal. - Positive control results:
- Phenylenediamine: Stimulation Index 9.0
- Parameter:
- SI
- Remarks on result:
- other: Negative Control: 1.0 Test Item 25%: 1.6 Test Item 50%: 1.8 Test Item 100%: 2.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test Item Conc. [%] Animal number DPM Negative 16 1043.0 Control 17 1721.0 18 1437.0 19 1153.0 20 1211.0 MV 1313.0 SD 241.1 Polyglykol 25 1 1430.0 BB 300 2 2436.0 in AOO 3 3705* 4 2101.0 5 2268.0 MV 2058.8 SD 381.8 Polyglykol 50 6 2320.0 BB 300 7 1982.0 in AOO 8 2690.0 9 2235.0 10 3640* MV 2306.8 SD 253.8 Polyglykol 100 11 2830.0 BB 300 12 2418.0 13 4107.0 14 4124.0 15 3305.0 MV 3356.8 SD 680.1 Background 16.0 Szinti and 13.0 TCA 10.0 10.0 13.0 MV 12.4 SD 2.2
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No significant skin sensitization potential was found for the registration substance. No classification is to be assigned.
- Executive summary:
The skin sensitization potential of the registration substance was investigated according to the OECD 429. Mice were treated topically on the ear with 0.1ml at concentration of 0, 25, 50 and 100% in AOO (4:1 (v/v) acetone/olive oil). The obtained SI values ranged 1.6, 1.8 and 2.6 at 25, 50 and 100% respectively. Based on the results obtained the registration substance is considered as a non-skin sensitizer.
Reference
Absolute Body Weights in g:
Concentration | Animal No. |
Start of Study |
End of Study |
Weight Gain |
1 | 21 | 22 | 1 | |
2 | 20 | 20 | 0 | |
Polyglykol BB 300 | 3 | 19 | 20 | 1 |
25% in AOO | 4 | 17 | 18 | 1 |
5 | 18 | 18 | 0 | |
6 | 19 | 21 | 2 | |
7 | 20 | 22 | 2 | |
Polyglykol BB 300 | 8 | 22 | 21 | -1 |
50% in AOO | 9 | 18 | 19 | 1 |
10 | 19 | 21 | 2 | |
11 | 22 | 22 | 0 | |
12 | 20 | 21 | 1 | |
Polyglykol BB 300 | 13 | 19 | 20 | 1 |
100% | 14 | 18 | 20 | 2 |
15 | 19 | 19 | 0 | |
16 | 21 | 21 | 0 | |
Negative | 17 | 21 | 21 | 0 |
Control | 18 | 18 | 18 | 0 |
100% AOO | 19 | 23 | 22 | -1 |
20 | 19 | 20 | 1 |
Clinical Observation
Time of Observation |
Systemic Effects |
Local Effects |
Group 1, animals no. 1 – 5 / test item at a concentration of 25% in AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf |
Day 4 |
nsf |
nsf |
Day 5 |
nsf |
nsf |
Day 6 |
nsf |
nsf |
Group 2, animals no. 6 – 10 / test item at a concentration of 50% in AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf |
Day 4 |
nsf |
nsf |
Day 5 |
nsf |
nsf |
Day 6 |
nsf |
nsf |
Group 3, animals no. 11 – 15 / test item at a concentration of 100% |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf |
Day 4 |
nsf |
nsf |
Day 5 |
nsf |
nsf |
Day 6 |
nsf |
nsf |
Group 4, animals no. 16 – 20 / negative control AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf |
Day 4 |
nsf |
nsf |
Day 5 |
nsf |
nsf |
Day 6 |
nsf |
nsf |
Ear Thickness - Preliminary Test
Animal No. | Measurement of Ear Thickness (mm) | ||||||
Concentration | Day 1 | Day 3 | Day 6 | ||||
left | right | left | right | left | right | ||
Polyglykol BB 300 50% in AOO |
1 | 0.20 | 0.19 | 0.22 | 0.21 | 0.20 | 0.21 |
Polyglykol BB 300 100% |
2 | 0.20 | 0.20 | 0.22 | 0.21 | 0.22 | 0.22 |
Negative Control 100% AOO |
3 | 0.20 | 0.20 | 0.19 | 0.20 | 0.20 | 0.21 |
Absolute Body Weights - Preliminary Test in g
Concentration | Animal No. |
Start of Study |
End of Study |
Weight Gain |
Polyglykol BB 300 50% in AOO |
1 | 25 | 25 | 0 |
Polyglykol BB 300 100% |
2 | 23 | 23 | 0 |
Negative Control 100% AOO |
3 | 23 | 24 | 1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
The skin sensitization property of the registration substance was investigated according to the OECD Guideline 429.
The registration substance is a non-skin sensitizer according to the results obtained in this study.
Justification for selection of skin sensitisation endpoint:
study on registration substance; scientifically well performed; Guideline study; GLP study
Justification for classification or non-classification
The skin sensitization property of the registration substance was investigated according to the OECD Guideline 429. No significant skin sensitization potential was found. No classification is to be assigned for the registration substance.
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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