N-(n-octyl)-2-pyrrolidinone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study according to GLP and internationally accepted standard procedure (comparable to guideline)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The assessment of the eye irritation potential is included in international regulatory requirements for the testing of chemicals. The HET-CAM Test is an alternative in vitro method for testing of severe eye/mucous membrane damage using the chorionallantoic membrane of fertilized, incubated hen eggs.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(n-octyl)-2-pyrrolidinone

EC Number:

403-700-8

EC Name:

N-(n-octyl)-2-pyrrolidinone

Cas Number:

2687-94-7

Molecular formula:

C12 H23 N O

IUPAC Name:

1-octylpyrrolidin-2-one

Details on test material:

- Name of test material (as cited in study report): N-(N-Octyl)pyrrolidone; Substance No. 91/453
- Physical state: colorless liquid
- Analytical purity: 99.3 %
- Lot/batch No.: FS 20628
- Storage condition of test material: refrigerator

Test animals / tissue source

Species:

other: Hen eggs in vitro

Results and discussion

In vitro

Results

Irritation parameter:

other: threshold concentration of test substance for effects indicating serious eye damage (mean time to coagulation < 90 sec)

Remarks on result:

positive indication of irritation

Remarks:

threshold concentration of NOP: 17 %

Any other information on results incl. tables

 

Concentration	Egg-No.	Time (sec) until appearance of :		Grading effects		Additional findings
		Haemorrhagia	Coagulation	Haemorrhagia	Coagulation
Test substance 10 % in Pluronic PR6200	1	135	150	2	2	iv
	2	128	133	2	2	iv
	3	159	200	2	1	iv
Mean	n = 3	141	161	2	2

 

Concentration	Egg-No.	Time (sec) until appearance of :		Grading effects		Additional findings
		Haemorrhagia	Coagulation	Haemorrhagia	Coagulation
Test substance 20 % in Pluronic PR6200	1	60	76	1	2	iv
	2	44	56	2	2	iv
Mean	n = 1	52	66	2	2

 

Concentration	Egg-No.	Time (sec) until appearance of :		Grading effects		Additional findings
		Haemorrhagia	Coagulation	Haemorrhagia	Coagulation
Test substance 40 % in Pluronic PR6200	1	36	46	2	2	iv
Mean	n = 1	36	46	2	2

 

Applicant's summary and conclusion

Interpretation of results:

corrosive