3-bis(diisopropylamino)phosphanyloxypropanenitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 13th 2018 to December 20th 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Version / remarks:

2015

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-({bis[bis(propan-2-yl)amino]phosphanyl}oxy)propanenitrile

EC Number:

600-337-9

Cas Number:

102691-36-1

Molecular formula:

C15H32N3OP

IUPAC Name:

3-({bis[bis(propan-2-yl)amino]phosphanyl}oxy)propanenitrile

Test material form:

liquid

Details on test material:

clear, colourless liquid

In vitro test system

Test system:

artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The test was performed on a total of 4 membrane discs with bio-barrier matrix together with a negative and positive control. A disc was placed on a vial with CDS fluid. The test item (500 μL) was applied on top of the matrix within two minutes after the disc was placed on the CDS fluid. One disc was exposed to 500 μL citric acid (10%, negative control) and one disc was exposed to 500 mg of the positive control sodium hydroxide. The test item and controls
were evenly distributed.

Duration of treatment / exposure:

The test item was classified into one of the two timescale categories.
The timescale category test showed that the test item is a timescale 2 item. No color change was observed in tube A and B, therefore the addition of the confirm reagent to tube B was performed. The addition of confirm reagent led to a color change of tube B into grey/purple indicating that the test item is a timescale 2 item.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

> 60

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the substance is classified as non-corrosive in the Corrositex® assay under the experimental conditions described in this report.

Executive summary:

The objective of this study was to evaluate the substance in the in vitro membrane barrier test for skin corrosion using Corrositex®.

For this purpose the test item was topically applied on top of a bio-barrier and the ability of the test item to pass through a bio-barrier and to elicit a color change in the underlying liquid

chemical detection system was evaluated.

The test item compatibility test showed that the test item was compatible with the chemical detection system. Based on the acid or alkali reserve of the chemical the test item was classified as a

timescale 2 compound. The test item was applied undiluted (500 μL) on top of the bio-barrier matrix. The elapsed time between application and penetration was determined by monitoring changes in the

chemical detection system. The test item did not penetrate through the membrane (mean penetration time >60 minutes).

The test passed all acceptance criteria:

a) The negative control citric acid (10%) showed a mean penetration time of >60 minutes and was therefore non-corrosive.

b) The positive control sodium hydroxide (as it is) breakthrough time (15 minutes) falls within within ± two standard deviations of the positive control historical mean breakthrough time.

c) The positive control sodium hydroxide (as it is) showed a mean penetration time of 15 minutes and was therefore classified as UN packing group II (=GSH 1B).

Overall it was concluded that the test system functioned properly. Since the test item was a timescale 2 test item and showed a mean penetration time of >60 minutes, the test item is

classified as non-corrosive.

In conclusion, The substance is classified as non-corrosive in the Corrositex® assay under the tested experimental conditions.