Fatty acids, C16 and C18-unsatd., polymers with bisphenol A, Bu glycidyl ether, epichlorohydrin and triethylenetetramine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 September 2012 to 17 January 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Fully GLP compliant and in accordance with current test guidelines

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

Test material form:

other: viscous semi-solid

Details on test material:

Name: MonoFA_TETA_PAA_BADGE_BGE_Adduct
CAS number: 105839-18-7
Batch number: WA 521
Purity: 100%
Expiry date: 28 Feb 2014
Receipt date: 3 Sep 2012
Storage: Stored in sealed container at 15 to 25°C, in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/CaCrl

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate.
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 18 to 20 g
- Housing: Individually housed in cages that conformed to the 'Code of Practicefor the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Main Diet No 1, ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 8 to 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 20 to 24°C
- Air changes (per hr): 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by flourescent strip-lights for twelve hours daily.

IN-LIFE DATES: From: 18 September 2012 To: 02 October 2012

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

Group number 1: Vehicle control
Group 2: Low concentration (10% w/v)
Group 3: Intermediate concentration (25% w/v)
Group 4: High concentration (50% w/v)

No. of animals per dose:

4 animals per dose group

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: Not reported
- Irritation: No signs of irritation

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Not reported
- Criteria used to consider a positive response: Not reported

TREATMENT PREPARATION AND ADMINISTRATION: Each mouse was manually restrained with both auditory pinnae left free. The outer aspect of both pinnae of each mouse was treated by direct application of the appropriate test or control formulation (0.025 mL/pinna) dispensed from an automatic micro pipette.

Positive control substance(s):

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

mercaptobenzothiazole (CAS No 149-30-4)

Statistics:

Not reported

Results and discussion

Positive control results:

Positive controls were not tested as a part of this test but are checked independently every 6 months,

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

15.2

Test group / Remarks:

10% w/v

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Scintillation fluid with 5% w/v trichloroacetic acid: 59 DPM Vehicle control: 2152 DPM Test article, 10% w/v: 32808 DPM Test article, 25% w/v: 39115 DPM Test article, 50% w/v: 37488 DPM

Results 3

Parameter:

SI

Value:

18.2

Test group / Remarks:

25% w/v

Results 4

Parameter:

SI

Value:

17.4

Test group / Remarks:

50% w/v

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The Local Lymph Node Assay demonstrated that MonoFA_TETA_PPA_BADGE_BGE_Adduct has the potential to cause skin sensitisation.
The test article was classified as a Category 1 sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

This study was conducted to assess the potential of the test article, MonoFA_TETA_PPA_BADGE_BGE_Adduct, to cause skin sensitisation in the mouse.

Following a preliminary screening test using a 50% w/v formulation, the test article was prepared for administration at 10, 25 and 50% w/v in 80% v/v acetone in olive oil. Groups of four female CBA/CaCrl mice were subjected to topical applications of vehicle or of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated ³H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph node were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.

Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from the controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.

	Concentration of test article in applied formulation (% w/v)
	10%	25%	50%
Stimulation Index	15.2	18.2	17.4

 

The Local Lymph Node Assay demonstrated that MonoFA_TETA_PAA_BADGE_BGE_Adduct has the potential to cause skin sensitisation.

The test article was classified as a Category 1sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).