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

Endpoint summary

Description of key information

Acute oral Toxicity: cute oral Toxicity:

LD₅₀ > 2000mg/kg body weight

Acute dermal Toxicity:

LD₅₀ >2000mg/kg body weight

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 November 2015 - 26 November 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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

Species:

rat

Strain:

Wistar

Sex:

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
- Weight at study initiation: variation did not exceed ±20% of the mean body weight
- Fasting period before study: overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: suspended solid floor polypropylene cages furnished with woodflakes
- Diet: free access to food
- Water: 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

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 2.11 mL/kg

No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Doses:

Starting dose: 300 mg/kg (absence of data regarding the toxicity of the test item)
2000 mg/kg

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0 (the day of dosing) and on Days 7 and 14; Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: yes

Preliminary study:

Dose Level - 300 mg/kg
There was no mortality.
No signs of systemic toxicity were noted during the observation period.
The animal showed expected gains in body weight over the observation period.
No abnormalities were noted at necropsy.

Key result

Sex:

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.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

An acute oral toxicity study was conducted (Envigo Research Limited, 2016, Study 41501807) to assess the toxicity of Dailube-IS following a single oral administration. The study was conducted in accordance with OECD 420 test guidelines and EU Method B.1 bis, and in compliance with GLP.

In accordance with the acute toxic class method, four fasted female Wistar rats were administered a single dose of 2000 mg/kg Dailube-IS by oral gavage.

There were no deaths at this dose level as well as no signs of systemic toxicity.

It was concluded that the acute median lethal dose in rats following oral administration of Dailube-IS was greater than 2000 mg/kg.

 

An acute dermal toxicity study was conducted (Envigo Research Limited, 2017, Study BG62LF) to assess the toxicity of Dailube-IS following a single dermal administration. The study was conducted in accordance with OECD test guideline 402 and EU Method B.3, and in compliance with GLP.

Five male and five female Wistar rats were administered a single dermal dose of 2000 mg/kg; the application site was wiped 24 hours after initial administration, then the animals were observed for 14 days.

There were no deaths during the observation period, no systematic response to treatment was observed, and no abnormalities were noted at necroscopy.

It was concluded that the acute median lethal dose in rats following dermal administration of Dailube-IS was greater than 2000 mg/kg.

No acute inhalation toxicity study was conducted as the available acute oral and dermal studies do not suggest acute toxicity via inhalation route.

The acute oral LD50 of Dailube-IS was determined to be greater 2000 mg/kg, on this basis Dailube-IS is not classified for acute dermal toxicity under the CLP Regulation.

The acute dermal LD50 of Dailube-IS was found to be greater than 2000 mg/kg; on this basis Dailube-IS is not classified for acute dermal toxicity under the CLP Regulation.

No test data is available as a basis to classify Dailube-IS for acute inhaled toxicity.