Amines, bis(C11-14-branched and linear alkyl), O,O-di-iso-Pr phosphorodithioates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-11-23 - 2011-11-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: in-vitro experiment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for Testing of Chemicals No. 437, September 07, 2009 (“Bovine Corneal Opacity and Permeability Test, Method for Identifying Ocular Corrosives and Severe Irritants”)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis-[N-C13-(branched and linear)-alykl]-ammonium O,O-dipropan-2-yl phosphorodithioate

EC Number:

700-768-3

Cas Number:

1285610-71-0

Molecular formula:

C26H56N.C6H14O2PS2

IUPAC Name:

Bis-[N-C13-(branched and linear)-alykl]-ammonium O,O-dipropan-2-yl phosphorodithioate

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

The test system (target tissue) is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

750 μL of the undiluted viscous test substance was applied directly to the epithelial surface of the cornea using a syringe (open chamber method). Each treatment group (test substance, NC and PC) consisted of 3 corneas.

Duration of treatment / exposure:

10 minutes followed by a 2-hours post-incubation period

Details on study design:

- Controls: Control tissues were concurrently applied into the anterior chamber with 750 μL of highly deionized water (negative control, NC) or with 750 μL of 1% (w/v) solution of sodium hydroxide in highly de-ionized water (positive control, PC) using a pipette.

Results and discussion

Any other information on results incl. tables

The BCOP test showed the following results:

Test substance	mean opacity value	mean permeability value	In Vitro irritancy Score
test article	2.5	-0.004	2.5
negative control	0.8	0.006	0.9
positive control	87.8	4.825	160.2

Based on the observed results it was concluded, that the test article does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

Applicant's summary and conclusion

Conclusions:

Based on the observed results it was concluded, that the test substance does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method does not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.