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EC number: 275-959-3 | CAS number: 71735-61-0
- 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 test item did not show sensitising properties in a LLNA in mice.
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:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18,8 - 21,4 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°
- Humidity (%):
- Air changes (per hr): 30-86
- Photoperiod (hrs light): 6.00 a.m. - 6.00 p.m. - Vehicle:
- methyl ethyl ketone
- Concentration:
- 6.25, 12.5, and 25 % (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- In addition to the sensitising reactions the following observations and data were recorded during the test and observation period:
Mortality / Viability once daily (week day) from experimental start to necropsy.
Body weights prior to the first application and prior to treatment with 3HTdR.
Clinical signs (local / systemic) at 1 – 2 hours after each application. Especially the treatment sites were observed carefully. - Positive control substance(s):
- not specified
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation
EC3 = (a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 3 on the local lymph node assay dose response plot. - Parameter:
- SI
- Remarks on result:
- other: see table below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table below
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be not a skin sensitiser in an in vivo Local Lymph Node Assay in mice under the described conditions.
- Executive summary:
In the study the test item dissolved in methyl ethyl ketone was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay in female CBA-mice was performed using test item concentrations of 6.25, 12.5, and 25 %. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
After the second application reddening of the ears could not be determined since the ear skin of the animals was dyed by the test item. In this study Stimulation Indices (S.I.) of 1.0, 1.0, and 1.1 were determined with the test item at concentrations of 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone, respectively.
The test item was not a skin sensitiser in this assay.
Reference
Test item Concentration |
Group |
DPM |
|
Calculation |
|
Result |
|
|
|
DPM-BG |
Lymph nodes (LN) |
DPM/LN |
SI |
|
BG I |
0 |
- |
- |
- |
- |
|
BG II |
9 |
- |
- |
- |
- |
|
CG 1 |
4661,5 |
4657,0 |
8 |
582,1 |
|
6,25 |
TG 2 |
4412,5 |
4408,0 |
8 |
551,0 |
1,0 |
12,5 |
TG 3 |
4500,4 |
4495,9 |
8 |
562,0 |
1,0 |
25 |
TG 4 |
4978,6 |
4974,1 |
8 |
621,8 |
1,1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification
No adverse effects were detected.
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