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

Endpoint summary

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:

01 February to 13 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant with current guidelines and GLP compliant

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)

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

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

Positive control results:

Stimulation index = 8.09

Parameter:

SI

Value:

2.02

Test group / Remarks:

4 animals, 2.5% concentration

Parameter:

SI

Value:

1.16

Test group / Remarks:

4 animals, 10% concentration

Parameter:

SI

Value:

2.89

Test group / Remarks:

4 animals, 50% concentration

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a study conducted in accordance with the OECD 429 guideline, the substance was tested for skin sensitisation potential in the mouse local lymph node assay.The Stimulation Index did not exceed 3 in any treatment group; therefore, the test material was considered to be a non-sensitizer under the conditions of the test.

Migrated from Short description of key information:
The substance is not a skin sensitizer based on the results of a Local Lymph Node Assay.

Justification for selection of skin sensitisation endpoint:
Key study conducted in accordance with OECD guideline and GLP standards.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Based on the result of the LLNA study conducted in accordance with the OECD 429 guideline, the test material does not meet the criteria for classification as a skin sensitizer under the terms of the CLP Regulation (EC) No 1272/2008.

Justification for classification or non-classification

Based on the result of the LLNA study the test material does not meet the criteria for classification as a skin sensitizer under the terms of the CLP Regulation (EC) No 1272/2008.