Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: 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 and environmental conditions:
TEST ANIMALS
- Females (if applicable) 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 °C
- 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 (if done): 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
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:
No signs of systemic toxicity were noted during the observation period.
There were no signs of dermal irritation.
Body weight:
All animals showed expected gains in body weight over the observation period.
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.