Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 June 2012 to 20 July 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted at a GLP compliant lab according to OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147,

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

EC Number:

700-792-4

Molecular formula:

C26H51NO2, C28H55NO2

IUPAC Name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Test material form:

other: SOLID

Details on test material:

- Name of test material (as cited in study report): t-1640l
- Physical state: solid
- Analytical purity:98.74%

- Purity test date:
- Lot/batch No.: 23-04-2013
- Expiration date of the lot/batch:12 Aoril 2013
- Radiochemical purity (if radiolabelling):

- Stability under test conditions: stable
- Storage condition of test material: +4C in the dark under dry conditions
- Other:

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Reputable industrial supplier
- Age at study initiation: 31 - 34 weeks
- Weight at study initiation: 3.83 - 4.76 kg
- Housing: Housed individually in plastic cages witrh perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet 125g/day
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 10-15 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20C
- Humidity (%): 40-70%
- Air changes (per hr): not recorded
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark

IN-LIFE DATES: From: To: 15 June 2012 to 20 July 2012

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca 0.5g applied as is to "wetted" treatment site
- Concentration (if solution): N/a

VEHICLE
- Amount(s) applied (volume or weight with unit): N/a
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

A single animal (number 20) received three exposures of three minutes, one or four hours
duration in a step-wise manner and acted as a preliminary screen. In the absence of a severe
effect on removal of the dressings the next exposure was initiated. In the absence of a severe
effect in this animal, two further animals were committed to the study receiving an exposure
of four hours.

Observation period:

Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later. Only the data for the four hour exposure are reported, the data from the three minute and one hour exposures are not reported. Additional observations of persistent effects of treatment were made daily to Day 12 in two animals.

Number of animals:

3 animals in total used

Details on study design:

TEST SITE
- Area of exposure: 25mm x 25mm area on dorso-lumbar region
- % coverage: 100%
- Type of wrap if used: 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape. For exposures of one hour or more each treatment site was covered with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM:

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: erythema noted in one rabbit only

Irritant / corrosive response data:

Very-slight or well-defined erythema was apparent in one animal throughout the first six days after bandage removal; exfoliation was evident for the following five days. No dermal reaction was observed in the remaining animals throughout the duration of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The Primary Irritation Index was calculated to be 0.7; T-1640L was classified as ‘mildly irritating’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008.