Reaction mass of Phenol, dodecyl-, sulfurized, calcium salts and benzene and butene and calcium carbonate and calcium dihydroxide and sulphur trioxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 February to 13 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant with current guidelines and GLP compliant

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 polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

EC Number:

903-161-3

IUPAC Name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Test material form:

liquid: viscous

Details on test material:

-Test Article ID: EC-903-161-3
- Physical state: Dark brown/black viscous liquid
- Lot/batch No.: LN09010643
- Expiration date of the lot/batch: 19 December 2013
- Storage condition of test material: Ambient temperature, in the dark

*EC 903-161-3 is exclusively synthesised and handled in solvent oil. Therefore testing was conducted on sample that contained 40.2% base oil and 59.8 % EC 903-161-3.

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: 16 to 19 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): 21°C to 22°C
- Humidity (%): 48% to 70%
- Air changes (per hr): 10
- 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 at 0% and 4 at each of 2.5%, 10% and 50%

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: No preparation. Dermal application 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 disintegrations per minute values

Results and discussion

Positive control results:

Stimulation index = 8.09

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

2.02

Test group / Remarks:

4 animals, 2.5% concentration

Results 2

Parameter:

SI

Value:

1.16

Test group / Remarks:

4 animals, 10% concentration

Results 3

Parameter:

SI

Value:

2.89

Test group / Remarks:

4 animals, 50% concentration

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, since treatment with EC 903 161 3 at concentrations of up to 50% did not achieve a stimulation index of =3, 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 study was to determine the delayed contact hypersensitivity potential of EC-903-161-3.

The study was performed using female CBA/Ca mice. The study design for the main study was as follows:

Text Table1
Experimental Design

Study Number	Group Number	Treatment	Formulation Concentration (%)	Animal Numbers
521627	1	Vehicle Control	0	1 to 6
521627	5	HCA	50	49 to 52
521674	1	EC-903-161-3	2.5	21 to 24
521674	2	EC-903-161-3	10	25 to 28
521674	3	EC-903-161-3	50	29 to 32

 

The stimulation indices (SI) for groups of mice that received EC-903-161-3 at concentrations of 2.5%, 10% or 50%, when compared with controls, were 2.02, 1.16 and 2.89, respectively. 

Under the conditions of the study, since treatment with EC-903-161-3 at concentrations of up to 50% did not achieve a stimulation index of =3, it was considered that the test item does not have the potential to cause skin sensitisation.