Registration Dossier
Registration Dossier
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EC number: 212-828-1 | CAS number: 872-50-4
Eye irritation
Administrative data
- Endpoint:
- eye 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
Reference
- 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
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- - treatment during complete period as single intraocular application
- additional animals treated for only 30 seconds (eye washed afterwards) - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- Not specified
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not specified, in additional animals
- Time after start of exposure: 30 s
SCORING SYSTEM: Draize method (Draize et al., 1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 41
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 40
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 34
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 8
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 35
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 26
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 18
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration). Value was not measured
- Irritant / corrosive response data:
- All the animals showed corneal involvement reversing within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21-day observation period and in washed eyes by day 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Moderate ocular effects observed according to the Draize score system.
- Conclusions:
- Corneal effects were reversible within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21 -day observation period and in washed eyes by day 14.
- Executive summary:
In an irritation study, New Zealand White rabbits received a single intraocular application of 0.1 mL neat NMP into the conjunctival sac of one eye, the other served as untreated control. Additional animals were dosed but their eyes were washed out 30 seconds after administration. Animals were observed for 21 days. Irritation was scored according to the method of Draize. Corneal effects were reversible within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21 -day observation period and in washed eyes by day 14. The ocular effects were rated as moderate.
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