Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 to 13 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant with OECD test guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

EC Number:

903-162-9

IUPAC Name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Test material form:

liquid: viscous

Details on test material:

- Material tested was a sample of EC-903-162-9 diluted in base oil. *
- Name of test material (as cited in study report): EC-903-162-9
- Physical state: Dark brown/black viscous liquid
- Lot/batch No.: LN07006926
- Expiration date of the lot/batch: 19 December 2013
- Storage condition of test material: Ambient temperature, in the dark

*EC 903-162-9 is exclusively synthesised and handled in solvent oil. Therefore testing was conducted on a sample that contained 40.8% Base oil and 59.2% EC 903-162-9.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River UK , Margate
- Age at study initiation: between 7 and 9 weeks old
- Weight at study initiation: approximately 16 to 20 g
- Housing: in pairs
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21°C to 22°C
- Humidity (%):): approximately 48% to 70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 01 to 13 February 2012

Study design: in vivo (LLNA)

Vehicle:

other: maize oil

Concentration:

0%, 2.5%, 10% and 50%

No. of animals per dose:

6 animals at 0% and 4 animals at each of the 2.5%, 10% and 50% concentrations

Details on study design:

RANGE FINDING TESTS:
- Irritation and toxicity

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay: dermal application
- Criteria used to consider a positive response: Stimulation indices greater than or equal to 3 in groups treated at either 2.5%, 10% or 50%

TREATMENT PREPARATION AND ADMINISTRATION: Dermal administration to the dorsum of the ears

Positive control substance(s):

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

Statistics:

Dixon's Q-test for the detection of a single outlier was performed on distintegrations per minute

Results and discussion

Positive control results:

Stimulation Index = 8.09

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Control group = 1, 2.5% group = 1.76, 10% group = 1.92, 50% group = 2.98

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Control group = 1533, 2.5% group = 2701, 10% group = 2937, 50% group = 4574

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, treatment did not achieve a stimulation index of =3; therefore, it was considered that the test item does not have the potential to cause skin sensitisation. This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes.

Executive summary:

The objective of this OECD 429 study was to determine the delayed contact hypersensitivity potential of EC-903-162-9.

The study was performed using female CBA/Ca mice. A preliminary test was conducted by administering a 50% concentration of test item to two mice. Each mouse received an open application of 25 µL of test formulation onto the dorsum of each ear.

As a result of the findings from the preliminary test, formulation concentrations were selected for the main study. Control animals from a concurrent study, Charles River Study, No. 521627, also acted as controls for this study. In addition, a group from the concurrent study was treated with hexylcinnamicaldehyde (HCA), a chemical known to induce skin sensitisation, in order to demonstrate that the selected vehicle, corn oil, was suitable for this test method. The study design for the main study was as follows:

Study Number	Group Number	Treatment	Formulation Concentration (%)	Animal Numbers
521627	1	Vehicle Control	0	1 to 6
521627	5	HCA	50	49 to 52
521669	1	EC-903-162-9	2.5	35 to 38
521669	2	EC-903-162-9	10	39 to 42
521669	3	EC-903-162-9	50	43 to 46

 

The vehicle control group received only corn oil. Each mouse received an open application of 25 µL of the appropriate formulation onto the dorsum of each ear for 3 consecutive days. Three days after the final application each animal received an intravenous injection of [methyl-³H] thymidine into the lateral tail vein. Approximately 5 h later the draining auricular lymph nodes were collected in order that incorporation of tritiated thymidine could be assessed by scintillation counting.

The stimulation indices (SI) for groups of mice that received the test aricle at concentrations of 2.5%, 10% or 50% were 1.76, 1.92 and 2.98, respectively. The group treated with HCA recorded a stimulation index of 8.09. This was considered to demonstrate competent performance of the test procedures.

Under the conditions of the study, since treatment did not achieve a stimulation index of =3, it was considered that the test item does not have the potential to cause skin sensitisation.