9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 June 2017 - 12 June 2017

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

July, 2013

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

EC Number:

308-415-1

EC Name:

9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

Cas Number:

97953-16-7

IUPAC Name:

9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

Specific details on test material used for the study:

Batch: RL55/17
Purity: 100%
Appearance: Yellow to brown paste
Expiry Date: 15 March 2018
Storage Conditions: At room temperature

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Test System: Freshly isolated bovine cornea (at least 9 month old donor cattle)

Test system

Vehicle:

physiological saline

Remarks:

20% suspension (w/v)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 mL

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

Triplicate

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

12.91

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Other effects / acceptance of results:

For the negative control (saline) an increase of neither opacity nor permeability of the corneae could be observed (mean IVIS = 1.36).

The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae (mean IVIS =126.28) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).

Any other information on results incl. tables

Results after 240 Minutes Treatment Time

Test Group	Opacity value = Difference (t240-t0) of Opacity	Permeability at 490 nm (OD490)	IVIS	Mean IVIS	Proposed in vitro Irritancy Score
Negative Control	Mean = 0.33	Mean = 0.068		1.36	Not categorized
Positive Control	121.67*	0.187*	124.47	126.28	Category 1
	116.67*	0.133*	118.66
	131.67*	0.271*	135.73
Substance	9.67*	0.197*	12.62	12.91	No prediction can be made
	14.67*	0.122*	16.49
	6.67*	0.197*	9.62

Applicant's summary and conclusion

Interpretation of results:

other: No prediction can be made.

Conclusions:

The substance is not serious eye damaging (CLP/EPA/GHS (Cat 1), but a prediction for the damage hazard cannot be made (GHS).

Executive summary:

An in vitro study was performed to assess the corneal damage potential of the substance by means of the BCOP assay using fresh bovine corneae. The 20% (w/v) suspension in saline of the substance, the positive, and the negative controls were applied to the different corneae and incubated for 240 minutes at 32 ± 1 °C. For the negative control (saline) an increase of neither opacity nor permeability of the corneae could be observed (mean IVIS = 1.36). The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae (mean IVIS =126.28) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). The substance was tested as suspension. Relative to the negative control, the substance caused an increase of the corneal opacity and permeability. The calculated mean IVIS was 12.91 (threshold for serious eye damage: IVIS > 55). According to OECD 437, no prediction for the damage hazard of the substance to the eye can be made. The substance is not serious eye damaging (CLP/EPA/GHS (Cat 1).