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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 May - 30 May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Experimental study conducted in GLP compliant lab according to EC and OECD test methods

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:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

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: white to pale yellow solid

Details on test material:

- Name of test material (as cited in study report): T-1640L
- Physical state: white to 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: refrigerated in the dark under dry conditions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited commercial supplier
- Age at study initiation: 8-12 weeks prior to dosing
- Weight at study initiation:384 - 407g (males) and 243 - 270g (females)
- Fasting period before study: N/a
- Housing: solid bottomed polycarbonate cages with a stainless steel mesh lid
- Diet (e.g. ad libitum): ad libitum, Rat and Mouse No. 1 Maintenance Diet
- Water (e.g. ad libitum): ad libitum, potable water from public supply
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23C
- Humidity (%): 40-70%
- Air changes (per hr): The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light):12hrs light/ 12hrs dark

IN-LIFE DATES: From: To: 10 May - 30 May 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 1% w/v methyl cellulose

Details on dermal exposure:

TEST SITE
- Area of exposure:dorso-lumbar region
- % coverage: 10%
- Type of wrap if used:porous gauze, held in place with a non-irritating dressing and further covered with a waterproof dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water (30-40C)
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):4 mL/kg bwt
- Concentration (if solution):500 mg/mL
- Constant volume or concentration used: yes constant concentration
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bwt
- Concentration (if solution): 1% w/v aqueous methyl cellulose
- Lot/batch no. (if required):Formulation prepared on day of dosing
- Purity: N/a

Duration of exposure:

24h exposure period

Doses:

2000 mg/kg bwt

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed twice daily but more frequently on day of dosing, weighed on days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,macropathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

Very slight to slight erythema with eschar/scab formation was seen in two females (C9,C10) after bandage removal on Day 2. These reactions had resolved by Day 10. No dermal reactions were seen in the remaining animals throughout the study.

Body weight:

Four females (C6,C7,C9,C10) showed a low bodyweight gain or a slight bodyweight loss on Day 8, however all males and females achieved satisfactory bodyweight gains on Day 15.

Gross pathology:

No abnormalities noted.

Other findings:

No systemic response to treatment in any animal

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal dermal dose (LD50) to rats of T-1640L was demonstrated to be
greater than 2000 mg/kg bodyweight.