Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005
Reference Type:
other: Amendment
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethylpyrrolidin-2-one
EC Number:
220-250-6
EC Name:
1-ethylpyrrolidin-2-one
Cas Number:
2687-91-4
Molecular formula:
C6H11NO
IUPAC Name:
1-ethylpyrrolidin-2-one
Details on test material:
purity: 99.8 corr. area-%
pH-value: ca. 7 (undiluted test substance)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. Deviations from these specifications that would have had an adverse effect on the test results did not occur. Illumination period was 12 h light (6.00 a.m. - 6 .00 p.m.) and 12 h darkness (6.00 p.m. - 6.00 a.m. Stainless steel wire mesh cages with grating were used; the animals were housed singly. The diet was Kliba Labordiät and water was available ad libitum. Acclimatization period was at least 5 days before the beginning of the study.
Before the beginning of application both eyes were investigated for signs of pre-existing irritation. Only animals with intact cornea and conjunctiva were used.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single ocular application
Observation period (in vivo):
The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 28.
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours after application the eye was rinsed with tap water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.2
Max. score:
2
Reversibility:
not fully reversible within: within 28 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.6
Max. score:
1
Reversibility:
fully reversible
Remarks:
within 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible
Remarks:
14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.9
Max. score:
2
Reversibility:
fully reversible
Remarks:
14 d

Any other information on results incl. tables

 

 

 

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

Opacity

Area of cornea involved

Redness

Chemosis

Discharge

1 h

01

0

0

0

3

3

3

49

02

0

0

0

2

3

3

49

03

0

0

0

2

3

3

49

24 h

01

1

2

0

2

1

1

PC, 48

02

1

4

1

3

2

2

PC, DB, 49

03

1

4

1

3

3

2

PC, DB, 49

48 h

01

1

1

0

2

1

1

PC, 48

02

1

4

1

3

2

2

PC, DB, 48

03

1

4

1

3

3

1

PC, DB, 49

72 h

01

1

1

0

2

1

0

PC, 48

02

2

4

0

3

2

1

PC, DB, 48

03

2

4

1

3

2

1

PC, DB, 49

7 d

01

0

0

0

0

0

0

SD

02

1

3

0

1

0

0

PC, 48

03

2

1

0

2

2

1

S, PC, 44, 49

14 d

02

1

1

0

0

0

0

44, 48

03

1

1

0

0

0

0

44, 48

21 d

02

0

0

0

0

0

0

SD

03

1

1

0

0

0

0

45, 48

28 d

03

1

1

0

0

0

0

45, 48

Mean
24 - 72 h

01

1.0

 

0.0

2.0

1.0

 

 

02

1.3

 

0.7

3.0

2.0

 

 

03

1.3

 

1.0

3.0

2.7

 

 

Mean

 

1.2

 

0.6

2.7

1.9

 

 

 

Explanation of findings:

S  = Suppuration

PC    = Pupil contracted

DB    = Discharge of blood

SD    = Study discontinued because the animal was free of findings

 

44 = Vascularization of the cornea, circumscribed area, marginal

45 = Vascularization of the cornea, circumscribed area, into the central part

48 = Scleral vessels injected, circumscribed area

49 = Scleral vessels injected, circular

Applicant's summary and conclusion

Conclusions:
Considering the described ocular reactions as well as the average score for irritation, N-Ethyl-2-pyrrolidon shows a severe eye irritation potential under the test conditions chosen.