Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 210-259-3 | CAS number: 611-20-1
- 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
Skin sensitisation: Sensitising, EC3=21%, mouse LLNA, OECD 429, Weber 2008
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:
- 2008-01-29 to 2008-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 19.0 - 23.0 g
- Housing: optimal hygienic conditions (OHC), single caging in Makrolon type II cages
- Diet: ad libitum, Ssniff Maintenance diet for rats and mice R/M-H (item V1534-3)
- Water: communal drinking water from Makrolon bottles, ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 (continuous monitoring)
- Humidity (%): 30 - 70% (continuous monitoring)
- Air changes (per hr): not reported (OHC)
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2008-01-29 To: 2008-02-05 - Vehicle:
- dimethylformamide
- Remarks:
- DMF allows highest test substance concentration
- Concentration:
- 25%, 50%, 64.8% (w/w),
equal to 37.5, 75, 97.2 mg test substance / animal - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 64.8 % (highest solubility found in any of the guideline-recommended vehicles)
- Irritation: Range finding study with 2 animals / concentration (64.8% and 50% w/w, applied 3 times on consecutive days): no systemic toxicity, no excessive local skin irritation, nor important increase in ear thickness
- Lymph node proliferation response: Concurrent positive control with 25% hexyl cinnamic aldehyde in acetone/olive oil proves the sensitivity of the strain of animals (main study).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node assay LLNA
- Criteria used to consider a positive response: induction of a 3-fold or greater increase in 3H-methyl thymidine incorporation in lymph node cells, relative to control lymph nodes, together with the consideration of dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
25 µl of the test compound solution in DMF was administered epicutaneously to the dorsal surface of each ear of each mouse. The application was repeated on days 2 and 3. On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Approximately five hours later, the draining auricular lymph node of each ear was rapidly excised into PBS; the lymph nodes of each group were pooled. A single cell suspension of lymph node cells was prepared by gentle mechanical disaggregation through a 70 micrometer cell strainer. The cell suspension was centrifuged (4°C, max. 200 g, 10 min) and washed twice with PBS. Cell macromolecules were precipitated with 5% trichloroacetic acid (TCA) at 4 °C overnight. Each precipitate was pelleted by centrifugation (as above) and resuspended in 1 ml TCA.
Suspensions were transferred to 10 mL scintillation cocktail, and 3H-TdR incorporation was determined with a beta-scintillation counter.
BODY WEIGHT:
- recorded on days 1 and 6
SKIN REACTIONS:
- application sites were visually checked for local irritations once daily (days 1-6) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Stimulation index (SI) = disintegrations per minute (dpm) in the test group (pooled) / dpm in the negative control group (pooled)
dpm corrected by subtraction of background - Positive control results:
- SI of positive control group (hexyl cinnamic aldehyde) = 16.2
- Parameter:
- SI
- Value:
- 4.1
- Test group / Remarks:
- Group A (low dose; 25% (w/w))
- Remarks on result:
- other: group K (negative control): 1 group P (positive control): 16.2
- Parameter:
- SI
- Value:
- 9.1
- Test group / Remarks:
- Group B (mid dose; 50% (w/w))
- Parameter:
- SI
- Value:
- 12.5
- Test group / Remarks:
- Group C (high dose; 64.8% (w/w))
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: group K (negative control): 2752 group A (low dose): 11186 group B (mid dose): 25022 group C (high dose): 34377 group P (positive control): 44455
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The substance is considered to be sensitising. The study is considered to be relevant and reliable.
Reference
BODY WEIGHT DEVELOPMENT:
- Weights and weight gains were within the expected range for this strain, sex, and age.
- Slight body weight losses were noted in animals of all groups, including negative and positive controls.
SYMPTOMS:
- No clinical signs in any animal.
SKIN REACTIONS:
- No local irritations in the negative control group and the three dose groups.
- Slight erythema of the application site in the positive control (day 3).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A single skin sensitisation study (Local Lymph Node Assay) conducted according to guideline OECD 429 and under GLP was available (Weber, 2008). The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. The LLNA resulted in stimulation indices above 3 at all concentrations tested; the test substance is therefore considered to be a sensitiser.
The EC3 value was not reported in the original study report, and has been calculated by the registrant for the purposes of classification and labelling in accordance with Commission Regulation (EU) No. 286/2011. The following dose response values were reported by Weber (2008):
Concentration
SI
Low dose (c,d)
c=25%
d=4.1
Mid dose (a,b)
a=50%
b=9.1
High dose
64.8%
12.5
Because no Stimulation Index was reported below 3, a linear interpolation could not be employed, and a log-linear extrapolation was used to determine the EC3 value (Extrapolating local lymph node assay EC3 values to estimate relative sensitizing potency, Ryan et al, Cutan Ocul Toxicol, 2007, 26(2), 135-145).
EC3(extrapolated)= 2^(log2(c)+(3-d)/(b-d)*(log2(a)-log2(c))) = 21%
where logarithms are base 2, and variable pairs (a,b) and (c,d) correspond to the mid and low doses respectively, on a SI vs concentration plot (see reference for further details).
The value EC3=21% was carried forward for potency classification purposes.
Justification for selection of skin sensitisation endpoint:
GLP study according to OECD testing guideline
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance meets the criteria for a sensitising substance according to the test method criteria in Regulation (EU) 440/2008, B.42. The derived EC3 value is >2%. As a result and in accordance with Regulation (EU) No. 1272/2008 as amended by Regulation (EU) No. 286/2011, 3.4.2.2.3.3, the substance is classified as a skin sensitiser Category 1B (H317: May cause an allergic skin reaction).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.