Trimethyloctylammonium methyl sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019.04.05~2019.05.21

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

OECD
Guidelines for the Testing of Chemicals, Section 4, TG 405 "Acute eye Irritation/Corrosion" (October 9, 2017)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethyloctylammonium methyl sulphate

EC Number:

265-332-2

EC Name:

Trimethyloctylammonium methyl sulphate

Cas Number:

65059-42-9

Molecular formula:

C11H26N.CH3O4S

IUPAC Name:

trimethyl(octyl)azanium methyl sulfate

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

NZW (KBL), Rabbit, SPF

Test system

Vehicle:

water

Observation period (in vivo):

24, 48 and 72 hours

Number of animals or in vitro replicates:

3 males (Initial test : 1 head,
Confirmatory test : 2 head)

Results and discussion

In vivo

Results

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

1

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The mean score of all animals was calculated as [1101 (Cornea (Opacity) : 1.0,
Conjuctivae (Redness) : 1.0, Chemosis (Swelling) : 1.0), 1201 (Cornea (Opacity) : 1.0,
Conjuctivae (Redness) : 1.0, Chemosis (Swelling) : 1.0), 1202 (Cornea (Opacity) : 1.0,
Conjuctivae (Redness) : 1.0, Chemosis (Swelling) : 1.0)].


As a result of acute eye irritation/corrosion test in rabbit, Trimethyloctylammonium
methyl sulphate was caused eye irritation and corrosion. Therefore, it was considered
to be classified as “Category 2/2A” according to Globally Harmonized System of
Classification and Labelling of Chemicals (GHS).

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

This study was performed to investigate the acute eye irritation and corrosion of
Trimethyloctylammonium methyl sulphate in rabbits. The 0.1 g of test substance was
applied to the eye and the parameters (mortality, clinical signs, body weights, eye
reactions) were observed up to 10 days. The results were as follows.
No clinical signs and mortality were observed relating to test substance treatment.
In body weight, the body weight decrease of one animal observed in the confirmatory
test was considered to be effect of the test substance administration with considering
to the eye reactions observed during experimental period.
Reversibility for the eye reaction of all animals observed in the initial and confirmatory
test was confirmed as the eye reaction was recovered within 10 days. And the eye
reaction was considered to be effect of the test substance administration as
considering comparison for control site of left eye.
The mean score of all animals was calculated as [1101 (Cornea (Opacity) : 1.0,
Conjuctivae (Redness) : 1.0, Chemosis (Swelling) : 1.0), 1201 (Cornea (Opacity) : 1.0,
Conjuctivae (Redness) : 1.0, Chemosis (Swelling) : 1.0), 1202 (Cornea (Opacity) : 1.0,
Conjuctivae (Redness) : 1.0, Chemosis (Swelling) : 1.0)].
As a result of acute eye irritation/corrosion test in rabbit, Trimethyloctylammonium
methyl sulphate was caused eye irritation and corrosion. Therefore, it was considered
to be classified as “Category 2/2A” according to Globally Harmonized System of
Classification and Labelling of Chemicals (GHS).