Quaternary ammonium compounds, trimethylsoya alkyl, chlorides

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From February to November 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, trimethylsoya alkyl, chlorides

EC Number:

263-134-0

EC Name:

Quaternary ammonium compounds, trimethylsoya alkyl, chlorides

Cas Number:

61790-41-8

Molecular formula:

Representative molecular formula of the major constituents, as the substance is an UVCB: C21H46Cl1N1 (C18 carbon chain) C21H44ClN (C18-unstatd. carbon chain)

IUPAC Name:

Quaternary ammonium compounds, trimethylsoya alkyl, chlorides

additive 1

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

propylene glycol

Test material form:

liquid

Details on test material:

Chemical name: Quaternary ammonium compounds, trimethylsoya alkyl, chlorides (TMAC S)
EC no.: 263-134-0

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant

Test animals / tissue source

Species:

chicken

Details on test animals or tissues and environmental conditions:

corneas

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent positive control

Amount / concentration applied:

5% (v/v) with concentrations of 60.3% and 3.015% active ingredient. (The diluted concentration (i.e. 3.015%) is equivalent to the maximum on-head hair colorant usage concentration).

Duration of treatment / exposure:

10 seconds followed by rinsing with 20ml saline

Duration of post- treatment incubation (in vitro):

0, 30, 75, 120, 180 and 240 minutes

Number of animals or in vitro replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

undiluted test substance

Value:

141

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

irritation index: 143

Remarks on result:

other: cornea: moderate erosion of the epithelium

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

5% (v/v) aqueous dilution

Value:

55

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

irritation index: 143

Remarks on result:

other: very slight swelling, slight opacity and slight to moderate fluorescein retention

Remarks:

cornea: very slight or slight erosion of the epithelium

Any other information on results incl. tables

Results (details):

The undiluted test substance produced severe irritation with an irritation index of 141/200. Histological examination of the corneas revealed moderate erosion of the epithelium with no effects on the stroma and endothelium being observed. The 5% (v/v) aqueous dilution of the test substance caused very slight swelling (5%), slight opacity (1.0) and slight to moderate fluorescein retention (1.5). The calculated Irritation Index was 55/200. Histological examination of the corneas treated with the diluted material revealed very slight or slight erosion of the epithelium, with no effects on the stroma and endothelium being observed.

Result table

Treatment	Maximum mean score for			Irritation Categories^*	IrritationIndex	Classification#
	Swelling %	Opacity	Fluorescein retention
Undiluted	21	3	3	III;IV;IV	141	Category 1
5% in sterile water	5	1.0	1.5	I;II;II	55	Not classified
Negative control	0	0.0	0.0	Not applicable	Not applicable	Not classified
Positivecontrol	23	3.0	3.0	III;IV;IV	143	Category 1

 *I = no effect, II = slight effect, III = moderate effect, IV = severe effect

#Classification according to EU CLP

 

Histology summary

Treatment	Tissue	Histological observations
Undiluted	1	Moderate erosion of the epithelium
	2	Moderate erosion of the epithelium
	3	Moderate erosion of the epithelium
5% in sterile water	1	Very slight erosion of the epithelium
	2	Very slight erosion of the epithelium
	3	Slight erosion of the epithelium
Negative control	1	No effects observed
	2
	3
Positive control	1	Moderate erosion of the epithelium
	2	Severe erosion of the epithelium
	3	Severe erosion of the epithelium

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

for the undiluted test substance

Conclusions:

Under the study conditions, the undiluted test substance induced irreversible effects on the eye and serious damage to the eye.

Executive summary:

A study was conducted to determine the in vitro eye irritant potential of the test substance, TMAC S (60.3% active), according OECD 438 Guideline (isolated chicken eye method), in compliance with GLP. Isolated chicken eyes were exposed to the test substance for 10 seconds, which were followed by evaluations at 0, 30, 75, 120, 180 and 240 minutes. The test substance was applied on cornea either undiluted or at a concentration of 5% (i.e., equivalent to 60.3 and 3.015% a.i.). The undiluted test substance produced severe irritation with an irritation index of 141/200. Histological examination of the corneas revealed moderate erosion of the epithelium with no effects on the stroma and endothelium being observed. The 5% (v/v) aqueous dilution of the test substance caused very slight swelling (5%), slight opacity (1.0) and slight to moderate fluorescein retention (1.5). The calculated Irritation Index was 55/200. Histological examination of the corneas treated with the diluted material revealed very slight or slight erosion of the epithelium, with no effects on the stroma and endothelium being observed. Under the study conditions, the undiluted test substance induced irreversible effects on the eye and serious damage to the eye, while the 5% (v/v) aqueous dilution was evaluated to cause only minimal or transient irritation. Therefore, the test substance was concluded to be corrosive to eyes (SCCS, 2012).