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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27th July - 15th August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in GLP Lab according to EEC and OECD test 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.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

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):
- Physical state: white-pale yellow solid
- Analytical purity: 98.74%
- Purity test date: 20 May 2011
- Lot/batch No.: 10121
- Expiration date of the lot/batch: 12 April 2013
- Stability under test conditions: stable
- Storage condition of test material: Under dry conditiond at ca. +4C in the dark
- Other:

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Stock animals originally from reputable industrial supplier
- Age at study initiation: 22-38 weeks
- Weight at study initiation: 3.18 - 4.49 kg
- Housing: animals were housed individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8-13 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: 25th July to 15th August 2012

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated left eye eas used as comparison with the treated right eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca 100 mg administered as supplied
- 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:

Treatment applied to right eye and observed for 4 days after installation

Observation period (in vivo):

4 day observation period although animals additionally assessed on Day 8 but data not reported

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a

SCORING SYSTEM: Kay and Calandra prescribed numerical system

TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h

Score:

1.3

Max. score:

1.3

Irritant / corrosive response data:

under the criteria of Kay and Calandra (1962) T-1640L was classified as “practically non-irritating” to the eye.

Other effects:

Injection of the conjunctival blood vessels with very-slight discharge was apparent in one animal one hour after instillation. No other sign of reaction to treatment was apparent.
Instillation of the test material gave rise to practically no initial pain response.

Any other information on results incl. tables



Applicant's summary and conclusion

Interpretation of results:

other: practically non-irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the criteria of Kay and Calandra (1962) T-1640L was classified as “practically non-irritating” to the eye.
T-1640L did not require labelling in accordance with European Commission regulation 1272/2008.