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EC number: 220-250-6 | CAS number: 2687-91-4
- 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 skin sensitizing potential of N-Ethyl-2-pyrrolidon was assessed using the nonradioactive variant of the Murine Local Lymph Node Assay (OECD 429). From the results of the study it is concluded, that N-Ethyl-2-pyrrolidon does not have a skin sensitizing effect (BASF, 2005).
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study. The study was modified to a non radioactive procedure. But this has no impact on the result.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted April 24, 2002
- Deviations:
- yes
- Remarks:
- non radioactive method, but no impact on the result
- Principles of method if other than guideline:
- The Murine Local Lymph Node Assay (LLNA) is recommended by international test guidelines (e.g. OECD) as an animal test for predicting skin sensitization in humans.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Batch No.: 29151288P0
Degree of purity / content: 99.8 corr. area-% - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- The single housed animals were identified by cage cards. The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. Deviations from these specifications that would have had an adverse effect on the test results did not occur. Illumination period was 12 h light and 12 h darkness. Acclimatization period 15 days before the first test substance application.
- Vehicle:
- other: aectone
- Concentration:
- 50%, 10% and 3% w/w preparations of the test substance in acetone
- No. of animals per dose:
- 6
- Details on study design:
- The study used 3 test groups and 1 control group. Each test animal was applied with 25 uL per ear of the respective test substance preparation to the dorsum of both ears for three consecutive days.
The control group was treated with 25 uL per ear of the vehicle alone.
Three days after the last application the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the cellular content (indicator of cell proliferation) and weight of each animal's pooled lymph nodes . Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each animal the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation. - Positive control substance(s):
- other: Alpha-Hexylcinnamaldehyde, techn . 85%
- Statistics:
- Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The indices of lymph node weight, cell count and ear weight were calculated as the ratio of the test group mean values for these parameters divided by those of the vehicle control group.
- Positive control results:
- As recommended by the respective testing guidelines, the following study was performed to evaluate the sensitivity of experimental animals and the ability of procedures to detect a known mild to moderate skin sensitizer.
Name of test substance: Alpha-Hexylcinnamaldehyde, techn . 85%
CAS number: 101-86-0
The mean indices (fold of change as compared to the vehicle control) for lymph node weight, cell count and ear weight are summarized for each test group in the table below.
Test group Treatment Lymph node Weight Index Cell Count Index Ear Weight Index
1 vehicle acetone 1 .00 1 .00 1 .00
2 1% in acetone 1 .12 1 .28 # 1 .04
3 3% in acetone 1 .37 # 1 .63 # 1 .06 #
4 10% in acetone 1 .96 ## 2 .94 ## 1 .14 ##
The statistical evaluations were performed using the WILCOXON-test ( # for p_< 0.05, ## for p< 0 .01 ) - Key result
- Parameter:
- SI
- Remarks on result:
- other: see below
- Remarks:
- The test substance did not induce a statistically significant or biologically relevant response of the auricular lymph nodes when applied as 3% or 10% preparations in acetone. The minimal but statistically significant increase in mice treated with the 50% test substance preparation was too small to be considered biologically relevant.
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA AND DETAILS ON STIMULATION INDEX CALCULATION
Test group Treatment Lymph node Weight Index Cell Count Index Ear Weight Index
1 Vehicle acteone 1.00 1.00 1.00
2 3% in acetone 0.95 0.99 1.05 #
3 10% in acetone 0.92 1.01 1.05 #
4 50% in acetone 1.20 # 1.32 # 1.05 #
The statistical evaluations were preformed using the WILCOXON-test( # for p<= 0.05 ## for p<= 0.01)
CLINICAL OBSERVATIONS:
No abnormalities were observed during general observation .
BODY WEIGHTS
The expected body weight gain was generally observed in the course of the study.
The test substance did not induce a statistically significant or biologically relevant response of the auricular lymph nodes when applied as 3% or 10% preparations in acetone. The minimal but statistically significant increase in mice treated with the 50% test substance preparation was too small to be considered biologically relevant. The statistically significant increases in ear weights, which were concentration independent, indicate irritation of the ear skin at all concentrations. The minimal increase in cell count and lymph node index in test group 4 is considered to be related to ear skin irritation produced by the combination of vehicle and test substance, which starts already at the 3% concentration without relevant lymph node response.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitizing potential of N-Ethyl-2-pyrrolidon was assessed using the nonradioactive variant of the Murine Local Lymph Node Assay (OECD 429). Choosing a non-radioactive variant is not considered to influence the validity of the test. Groups of 6 female CBA/Ca mice each were treated with 50%, 10% and 3% w/w preparations of the test substance in acetone or with the vehicle alone. The test substance did not induce a statistically significant or biologically relevant response of the auricular lymph nodes when applied as 3% or 10% preparations in acetone. The minimal but statistically significant increase in mice treated with the 50% test substance preparation was too small to be considered biologically relevant. Beyond this the statistically significant increases in ear weights, which were concentration independent, indicate irritation of the ear skin at all concentrations. Thus, the minimal increase in cell count and lymph node index in test group 4 is considered to be related to ear skin irritation produced by the combination of vehicle and test substance, which starts already at the 3% concentration without relevant lymph node response.
From the results of the study, it is concluded that N-Ethyl-2 -pyrrolidon does not have a skin sensitizing effect in the Murine Local Lymph Node Assay.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification is not warranted according to the criteria of the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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