Registration Dossier
Registration Dossier
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EC number: 212-828-1 | CAS number: 872-50-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The acute oral toxicity and primary ocular and dermal irritation of selected N-alkyl-2-pyrrolidones
- Author:
- Ansell JM & Fowler JA
- Year:
- 1 988
- Bibliographic source:
- Fd. Chem. Toxicol. 26, No. 5: 475-479
- Reference Type:
- publication
- Title:
- 1-methyl-2-pyrrolidone, SIDS Initial Assessment Report For SIAM 24
- Author:
- OECD HPV Chemicals Programme
- Year:
- 2 007
- Bibliographic source:
- OECD HPV Chemicals Programme, SIDS Dossier, approved at SIAM 24 (19-20 April 2007)
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-methyl-2-pyrrolidone
- EC Number:
- 212-828-1
- EC Name:
- 1-methyl-2-pyrrolidone
- Cas Number:
- 872-50-4
- Molecular formula:
- C5H9NO
- IUPAC Name:
- 1-methylpyrrolidin-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Source: GAF Chemicals Corporation, Wayne, NJ, USA
- Purity: >= 98%, with less than 0.5% of water
Test animals
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Remarks:
- back on one side abraded using a sterile 22-gauge needle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Skin of the back
- Type of wrap if used: gauze pad secured with an adhesive tape, covered with occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: water moistened towel, skin wiped afterwards
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to Draize (Draize et al. 1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritant / corrosive response data:
- Effects ranged fom none to barely perceptible erythema without oedema clearing within 72 hours.
Any other information on results incl. tables
Rabbit |
Skin |
24 hours |
72 hours |
7 days |
|||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
1 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
4 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
5 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
6 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
Mean |
I |
1.0 |
0 |
0 |
0 |
0 |
0 |
|
A |
1.0 |
0 |
0 |
0 |
0 |
0 |
A: abraded skin, I: intact skin
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal response was rated as minimal.
- Executive summary:
In a primary dermal irritation study albino rabbits were dermally exposed to undiluted NMP similar to OECD guideline 404.
Approximately 0.5 mL NMP was applied to the backs of 6 rabbits that had been closely abraded. The undiluted NMP was applied to the intact (concurrent control) and abraded skin. When the examination was repeated 72 hours after the start of exposure, no effects were observed. The tests showed a low potential for skin irritation and resulted (for both intact and abraded skin and averaged reading from 24 and 72 hours) in a primary irritation index (PII) of 0.5.
The dermal response was rated as minimal. Although the results of this study will not lead to classification, the EU has classified NMP as irritating 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.
