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EC number: 210-483-1 | CAS number: 616-45-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-13 to 2003-05-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD 404; US EPA , OPPTS 870.2500; EU Method B.4 and JMAFF, Japanese test guideline without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The testing facilty indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The testing facilty indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Remarks:
- The testing facilty indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF , Japanese guideline
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-pyrrolidone
- EC Number:
- 210-483-1
- EC Name:
- 2-pyrrolidone
- Cas Number:
- 616-45-5
- Molecular formula:
- C4H7NO
- IUPAC Name:
- pyrrolidin-2-one
- Test material form:
- solid
- Details on test material:
- - Name of test material: HC1161
- Substance type: pure active substance
- Physical state: colourless-white solid
- Analytical purity: not indicate by sponsor, treated as 100 % pure
- Expiration date of the lot/batch: 2003-07-31
- Stability under test conditions: stable under storage condition
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet: approx. 100 g standard laboratory rabbit diet per day, pressed hay twice a week
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 22.5
- Humidity (%): 38 - 7
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours artificial fluorescent light per day
IN-LIFE DATES: From: 2003-05-13 To:2003-05-30
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not treated skin of treated animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4hr
- Observation period:
- at 1, 24 48, 72 hrs
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area free of fur (150 square centimeters)
- % coverage: no data
- Type of wrap if used: metalline patch of 2x3 cm
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4hr
SCORING SYSTEM:
Eyrthema and eschar formation:
0 No erythem
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to sever erythema
4 Severe erythema (beet redness)
Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (=4) is given.
Oedema formation:
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (raised approximately 1 millimeter)
4 Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 312 (sentinel)
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 312 (sentinel)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 338
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: After 1 hour the same observations were made.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 348
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: After 1 hour the same observations were made.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 312 (sentinel)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: After 1 hour the same observations were made.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 338
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: After 1 hour the same observations were made.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 348
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: After 1 hour the same observations were made.
- Irritant / corrosive response data:
- -Irritation: at 4 h exposure to 0.5 g of HC1161 resulted in very slight erythema in treated skin-area of 1/4 rabbit, which had resolved within 24 hours after exposure (see Remarks on results").
-Corrosion: There was no evidence of a corrosive effect on the skin. - Other effects:
- -Colouration: No staining of the treated skin by the test substance was observed.
-Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
Table: Individual Skin Irritation Scores |
|||||||||
Animal # |
312 (sentinel) |
338 |
348 |
||||||
Time after exposure |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
1 hour |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
24 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
48 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
72 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- 1 rabbit reversible (within 24 h) slight irritation (after 4 h exposure). Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- According to EC criteria for classification and labelling the HC1161 (2-pyrrolidone) does not have to be classified and has no obligatory labelling requirement for skin irritation.
- Executive summary:
The study was conducted in compliance with the OECD Guideline 404 and GLP. The objective of this primary skin irritation study was to assess the irritation potential of a single dose of the test substance administered to the intact skin of rabbits. Three rabbits were exposed to 0.5 gramm of HC1161 (2 -pyrrolidone), applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observation were made 1, 24, 48 and 72 hours after exposure.
No skin irritation was observed after exposure. The test material is not irriating to the skin.
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