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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 February 2017 - 14 March 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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: L003
Purity: 95.5%
Physical state/Appearance: pale yellow liquid
Expiry Date: 11 January 2018
Storage Conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks of age
- Weight at study initiation: at least 200 g, variation did not exceed ±20% of the mean weight for each sex
- Housing: suspended solid floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access to food
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: surgical gauze and semi occluded with a piece of self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: wiped with distilled water
- Time after start of exposure: 24 Hour contact period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 Hour contact period

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
deaths or overt signs of toxicity: 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
Individual body weights: Day 0, Days 7 and Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic abnormalities

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period. There were no signs of dermal irritation.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.