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EC number: 605-200-7 | CAS number: 160194-28-5
- 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:
- 18 June 2014 to 14 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted following OECD/EU guideline "Principles on Good Laboratory Practice (GLP) (as revised in 1997), ENV/MC/CHEM (98) 17" and in accordance with GLPStudy material is well characterized.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx 9 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: labeled Makrolon cages
- Diet: free access to pelleted rodent diet
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 degrees celcius
- Humidity (%): 40 -70%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark
IN-LIFE DATES:
To: 18 June 2014
Completion : 14 July 2014 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- In the pre-screen study: Two test substance concentrations were tested; a 100% and 50% concentration. The highest concentration was the maximum concentration as required in the test guidelines (undiluted for liquids, 50% for solids).
In the main study, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 10, 25 or 50% w/w on three consecutive days, by open application on theears. Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive oil (4:1 v/v)). - No. of animals per dose:
- Three groups of five animals were treated with one test substance concentration per group. One group of five animals was treated with vehicle.
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: not indicated
- Irritation: Once daily on Days 1-6 (on Days 1-3 within 1 hour after dosing) according to the following numerical scoring system. Furthermore, a description of all other (local) effects was recorded.
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION: The test substance formulations (w/w) were prepared within 4 hours prior to each dosing. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
Correction of the purity/composition of the test substance is not applicable, since the test method requires a logical concentration range rather than specific dose levels to be dosed.
Administration:
Induction - Days 1, 2 and 3
The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance concentration, at approximately the same time on each day.
Excision of the nodes - Day 6
Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) (Merck, Darmstadt, Germany) containing 20 μCi of 3H-methyl thymidine (PerkinElmer Life and Analytical Sciences, Boston, MA, US). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node
Assay as performed at WIL Research Europe is an appropriate model for testing for contact
hypersensitivity. - Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 10, 25 and 50% were 0.8, 1.7 and 4.8, respectively. SI results in table below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 243, 539 and 1511 DPM, respectively. The mean DPM/animal value for the vehicle control group was 315 DPM. DPM values are presented for each animal and for each dose group in table below (other information)
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- These results indicate that the test substance could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 35.4% was calculated.
Based on these results:
- according to the recommendations made in the test guidelines (including all amendments), Bis-Tes (dried) would be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments), Bis-Tes (dried) should be classified as skin sensitizer (Category 1B).
- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments), Bis-Tes (dried) should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.
Reference
Relative size lymph nodes, radioactivity counts (DPM) and Stimulation Index (SI)
Group |
TS (%)1 |
Animal |
Size nodes2 Left Right |
DPM3/animal |
Mean DPM ± SEM4 |
Mean SI ± SEM |
1 |
0 |
1 2 3 4 5 |
n n n n n n n n n n
|
209 287 286 333 459 |
315 ± 41 |
1.0 0.2 |
2 |
10 |
6 7 8 9 10 |
n n n n n n n n n n
|
218 188 245 336 227 |
243 ± 25 |
0.8 ± 0.1 |
3 |
25 |
11 12 13 14 15 |
n n n n n n n n n n
|
289 526 1015 502 362 |
539 ± 127 |
1.7 ± 0.5 |
4 |
50 |
16 17 18 19 20 |
n n n n n n n n n n
|
1008 2142 1168 2430 805 |
1511 ± 325 |
4.8 ± 1.2 |
1. TS=test substance (%w/w).
2. Relative size auricular lymph nodes(-,--or---:degree of reduction,+,++ or +++: degree of enlargement, n: considered to be normal).
3. DPM=Disintegrations per minute
4. SEM=Standard Error of the Mean
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Migrated from Short description of key information:
One key study, an in-vivo local lymph node assay conducted following OECD and EU guidelines and under GLP conditions.
Justification for selection of skin sensitisation endpoint:
ASSESSMENT OF CONTACT HYPERSENSITIVITY TO BIS-TES (DRIED) IN THE MOUSE (LOCAL LYMPH NODE ASSAY) . Conducted according to OECD and EU guidelines and under GLP conditions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
ASSESSMENT OF CONTACT HYPERSENSITIVITY TO BIS-TES (DRIED) IN THE MOUSE (LOCAL LYMPH NODE ASSAY) . The results indicate that the test substance could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 35.4% was calculated. Therefore the test substance would be classified as a skin sensitizer 1.
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