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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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.
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.
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