1,3-bis(2,4,4-trimethylpentan-2-yl)trisulfane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 November 2015 - 04 November 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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)

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

bis(2,4,4-trimethylpentan-2-yl)trisulfane

EC Number:

941-787-9

Cas Number:

98222-50-5

Molecular formula:

C16 H34 S3

IUPAC Name:

bis(2,4,4-trimethylpentan-2-yl)trisulfane

Test material form:

liquid

Details on test material:

Name: DAILUBE IS-30
Chemical Name: 1, 3-bis (2, 4, 4-trimethylpentan-2yl) trisulfane
Use: Lubricant Additive
Molecular Formula: CH3-C(CH3)2-CH2-C(CH3)2-SSS-C(CH3)2-CH2-C(CH3)2-CH3
Molecular Weight: 322 g/mol
Appearance Pale yellow
Physical State: Liquid
Batch Number: L002
Purity: 95.4% by weight
Storage: Room temperature, in the dark
Expiry Date: 2016/8/15

Specific details on test material used for the study:

Batch: L002
Purity: 95.4%
Physical state/Appearance: pale yellow liquid
Expiry Date: 15 August 2016
Storage Conditions: room temperature in the dark

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: local abattoir
- Age of animals: 12 to 60 months old
- Storage: refrigerated on arrival and used within 24 hours of receipt

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 mL of the test item or control items

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

120 minutes

Number of animals or in vitro replicates:

3

Details on study design:

SELECTION AND PREPARATION OF CORNEAS: Only corneas free of damage were used.

QUALITY CHECK OF THE ISOLATED CORNEAS: macroscopically examined before and after dissection

NUMBER OF REPLICATES: 3

NEGATIVE CONTROL USED: 0.9% w/v sodium chloride solution

POSITIVE CONTROL USED: Ethanol

APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL of the test item or control items for 10 minutes at 32 ± 1 ºC

TREATMENT METHOD: open chamber

POST-INCUBATION PERIOD: yes, 120 minutes

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 4
- POST-EXPOSURE INCUBATION: 120 minutes

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Each cornea was visually observed
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microplate reader (OD492)
- Histopathology: possible conduct of histopathology

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA:
IVIS CLASSIFICATION
≤ 3 No category. Not requiring classification to UN GHS or EU CLP
> 3; ≤55 No prediction of eye irritation can be made
> 55 Category 1. UN GHS or EU CLP Causes serious eye damage

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Main

Value:

1.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Corneal Opacity and Permeability Measurement: Table 1
Corneal Epithelium Condition: Table 2

Any other information on results incl. tables

Table 1     Individual and Mean Corneal Opacity and Permeability Measurements

 

Treatment	CorneaNumber		Opacity				Permeability(OD)		InVitroIrritancyScore
		Pre-Treatment	Post-Treatment	PostIncubation	Post-Incubation -Pre-Treatment	CorrectedValue		CorrectedValue
Negative Control	19	4	5	5	1		0.006
	22	4	4	6	2		0.004
	23	4	4	6	2		0.001
					1.7*		0.004¨		1.7
Positive Control	5	3	35	33	30	28.3	0.446	0.442
	18	3	35	34	31	29.3	1.308	1.304
	24	4	31	29	25	23.3	0.880	0.876
						27.0·		0.874·	40.1
Test Item	26	4	4	4	0	0.0	0.065	0.061
	27	3	4	4	1	0.0	0.006	0.002
	28	4	3	9	5	3.3	0.008	0.004
						1.1·		0.023·	1.5

 

 OD=Opticaldensity       *=Meanofthepost-incubation-pre-treatmentvalues      ¨=Meanpermeability                      ·=Meancorrectedvalue

Table 2     Corneal Epithelium Condition Post Treatment and Post Incubation

 

Treatment	CorneaNumber	Observation
		PostTreatment	PostIncubation
Negative Control	19	clear	clear
	22	clear	clear
	23	clear	clear
Positive Control	5	cloudy	cloudy
	18	cloudy	cloudy
	24	cloudy	cloudy
Test Item	26	clear	clear
	27	clear	clear
	28	clear	clear

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No category. Not requiring classification to UN GHS or EU CLP.