1H-Pyrazole-5-carboxylic acid, 1-(3-chloro-2-pyridinyl)-3-[[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-

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: GLP study according EU/OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

Version / remarks:

(2009)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid

EC Number:

936-882-7

Cas Number:

1352319-02-8

Molecular formula:

C12H7ClF3N7O2

IUPAC Name:

1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid

Test animals / tissue source

Species:

other: chicken

Strain:

other: isolated chicken eye´s

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: concurrent control eyes treated with saline served as negative controls, positive controls were exposed to imidazole

Duration of treatment / exposure:

10 seconds

Observation period (in vivo):

4h

Results and discussion

In vitro

Results

Irritation parameter:

other:

Remarks:

see below "Any other information on results incl. tables"

Run / experiment:

see below "Any other information on results incl. tables"

Remarks on result:

other: see below "Any other information on results incl. tables"

Remarks:

see below "Any other information on results incl. tables"

Any other information on results incl. tables

Experimental result:

Test item

Observation	Value	ICE Class*
Mean maximum corneal swelling at up to 75 min	0 %	I
Mean maximum corneal swelling at up to 240 min	0 %	I
Mean maximum corneal opacity	2.67	IV
Mean fluorescein retention	1.00	II
Other Observations	None.
Overall ICE Class*	1xI 1xII 1xIV

Positive control

Observation	Value	ICE Class*
Mean maximum corneal swelling at up to 75 min	2 %	I
Mean maximum corneal swelling at up to 240 min	6 %	II
Mean maximum corneal opacity	4.00	IV
Mean fluorescein retention	3.00	IV
Other Observations	The Imidazole was stuck on the cornea surface after the post-treatment rinse. The cornea surface was not cleared 240 minutes after the post-treatment rinse.
Overall ICE Class*	1xII 2xIV

Negative control

Observation	Value	ICE Class*
Mean maximum corneal swelling at up to 75 min	0 %	I
Mean maximum corneal swelling at up to 240 min	0 %	I
Mean maximum corneal opacity	0.00	I
Mean fluorescein retention	0.00	I
Other Observations	None
Overall ICE Class*	3xI

Applicant's summary and conclusion

Conclusions:

Based on this in vitro eye irritation in the isolated chicken eyes test with the test item, the test item is not classified as a severe irritant and not classified as non-irritant. It is concluded that an in vivo study is required for classification.