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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
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- 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
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- 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
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- 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: Notox B.V., 2003. Primary skin
irritation /corrosion study with HC1161 in rabbits (4-hour
semi-occlusive application). Report No. 379474. According to the OECD
guideline 404, rabbits, New Zealand White, 4 h, semiocclusive, 0.5 g.
Eye: BASF AG, 1961. Results of the toxicological pretesting, Pyrrolidone
distilled. Report No. IX/407. BASF Test, comparable to the OECD
guideline 405, rabbits, Vienna White, 0.05 mL.
Respiratory system: no data available
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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
- 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 - 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) - 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. - 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.
Reference
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 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable data which meets basic scientific principles, with acceptable restrictions (purity of the test substance not specified)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: BASF Test comparable to OECD Guideline 405
- Principles of method if other than guideline:
- BASF-Test. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
- GLP compliance:
- no
- Remarks:
- The study was performed prior to the adoption of the GLP requirements
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Body weight at test initiation: 2.46 and 3.2 kg, respectively
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: physiological saline was applied to the left eye, which served for control
- Amount / concentration applied:
- Amount applied: 0.05 mL
- Duration of treatment / exposure:
- unspecified (eyes were not washed)
- Observation period (in vivo):
- until complete reversibility of the effects was observed: 6 d (animal 1)/7 d (animal 2)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: Draize (The original findings for both animals (referred to as 1 and 2) were converted into a numerical scoring system according to Draize)
TOOL USED TO ASSESS SCORE: fluorescein (at the final reading) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- 2-pyrrolidone is considered to be irritating to the rabbit eyes (Category II).
- Executive summary:
In a study in rabbits 2-pyrrolidone was investigated for its potential to induce eye irritation/corrosion. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The test item produced in the present eye irritation test alterations at the cornea and conjunctivae. The iris was not affected. The observable effects were fully reversible until the end of the study.
Based on corneal opacity (24-72h score is 2 across 2 test animals), 2-pyrrolidone is classified for its eye irritation potential as follows: irritating to eyes Cat.2 (EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulations No. 1271/2008).
Reference
Reading | animal | cornea | iris | conjunctivae | |
No. | opacity | redness | swelling | ||
24 h | 1 | 2 | 0 | 1 | 0 |
24 h | 2 | 2 | 0 | 2 | 0 |
48 h | 1 | 2 | 0 | 1 | 0 |
48 h | 2 | 2 | 0 | 1 | 0 |
72 h | 1 | 2 | 0 | 0 | 0 |
72 h | 2 | 2 | 0 | 0 | 0 |
6 d | 1 | 0 | 0 | 0 | 0 |
6 d | 2 | 2 | 0 | 0 | 0 |
7 d | 2 | 0 | 0 | 0 | 0 |
relevant for classification: | |||||
mean | 1 | 2 | 0 | 0.7 | 0 |
24-72h | 2 | 2 | 0 | 1 | 0 |
mean | 2 | 0 | 0.8 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a GLP- and OECD-compliant irritation study, undiluted 2 -pyrrolidone at single dose was applied occlusive to the rabbits skin. No erythema or oedema were observed after 24, 48 and 72 hours after exposure (Notox B.V., 2003). No signs of systemic toxicity were observed in the animals during the study. The test material is considered to be not irritating if applied to the skin.
A Draize test was performed with six White Vienna rabbits (BASF AG 1981). A 24-hour occlusive exposure to 0.5 g of the unchanged test substance produced reversible minor erythema and no edema (overall erythema score of 1.06 for the readings 24, 48 and 72 h) and scaling in 2/6 animals persisting to the final reading on day 8.
In a second report, two rabbits were exposed to the unchanged test substance for 20 h under occlusive conditions (BASF AG 1961). Slight erythema (overall erythema score of 1.00 for the readings 24, 48 and 72 h) were reversible at least within 8 days, edema were not observed, while scaling was reported for the final reading on day 8.
Both results should be considered as overpredictive due to the harsh test conditions if compared to actual guideline recommendations (4 h under semiocclusive conditions).
Eye irritation
In the BASF eye irritation study (BASF, 1961), only two test animals were used. The mean corneal opacity score (24 -72h) was 2. The test material induced also conjunctivae alterations. The iris was not affected. The observable effects were fully reversible until the end of the study.
Respiratory system
No data available
Justification for classification or non-classification
Skin irritation
Classification is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulations No 1272/2008.
Eye irritation
Based on corneal opacity (24-72h score is 2 across 2 test animals), 2-pyrrolidone is classified for its eye irritation potential as follows: irritating to eyes Cat.2 (EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulations No. 1271/2008).
Respiratory system
Actually, there is no indication given for a classification according to this endpoint.
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