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

Endpoint summary

Description of key information

Ski sensitisation:

The test item was considered to be a non-sensitizer under the conditions of the test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 November 2015 - 08 December 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Version / remarks:

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.

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Version / remarks:

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.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

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:

mouse

Strain:

CBA/Ca

Sex:

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 old
- Weight at study initiation: 15 to 23 g
- Housing: suspended solid floor polypropylene cages furnished with softwood woodflakes
- Diet: Free access to food
- Water: Free access to mains tap water
- Acclimation: period: at least 5 days

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

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

25%, 10% or 5% v/v

No. of animals per dose:

4

Details on study design:

PRE-SCREEN TESTS:
- Irritation: measured
- Systemic toxicity: measured
- Ear thickness measurements: measured
- Erythema scores: measured

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Pooled Method
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

Concentration (% v/v) in
acetone/olive oil 4:1 Stimulation Index Result
25 6.08 Positive

α Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.

Key result

Parameter:

SI

Value:

1.69

Test group / Remarks:

Concentration in acetone/olive oil 4:1: 5 % v/v

Key result

Parameter:

SI

Value:

2.61

Test group / Remarks:

Concentration in acetone/olive oil 4:1: 10 % v/v

Key result

Parameter:

SI

Value:

2.84

Test group / Remarks:

Concentration in acetone/olive oil 4:1: 25 % v/v

Cellular proliferation data / Observations:

See Table 1.

Table 1       Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index

Concentration (% v/v) in acetone/olive oil 4:1	dpm	dpm/Node a	Stimulation Index b	Result
Vehicle	15046.38	1880.80	na	na
5	25366.65	3170.83	1.69	Negative
10	39210.85	4901.36	2.61	Negative
25	42781.98	5347.75	2.84	Negative

dpm =       Disintegrations per minute

a =       Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)

b =              Stimulation Index of 3.0 or greater indicates a positive result

na  =              Not applicable

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered to be a non-sensitizer under the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A local lymph node assay in the mouse was conducted (Envigo Research Limited, 2016, 41501810) to determine the potential for Dailube-IS to cause delayed-action dermal effects. The study was performed according to OECD test guideline 429 and EU Method B.42, and in compliance with GLP.

 

Three groups of four CBA/ Ca strain mice were dosed for three consecutive days with 25 µL of test material in acetone : olive oil (4:1 v/v) at concentrations of 50%, 25%, 10% (v/v), or 5%. Sensitization was determined in terms of the proliferative response from the draining auricular lymph nodes, measured by the uptake of 3H-methyl thymidine by beta-scintillation counting of lymph node cells.

 

None of the dose groups showed a threefold or greater response relative to the concurrent control group, and so Dailube-IS was not considered to be sensitizing.

 

LLNA, Mice - Not sensitising.

As noted above, a Skin Sensitization study concluded that Dailube-IS showed no sensitizing activity; on this basis Dailube-IS is not classified for skin sensitization under the CLP Regulation.

No information regarding the potential for Dailube-IS to cause respiratory sensitization.