1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-01 to 1999-05-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant Guideline study.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Reference 2

Reference Type:

other: Amendment Final Report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Remarks:

(two limit tests)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-370-5

EC Name:

-

Cas Number:

220410-74-2

Molecular formula:

C34H67N3O13

IUPAC Name:

tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate

Test material form:

other: Ivory-peach flakes

Details on test material:

- Identification: TKA 45021
- Appearance: Ivory-peach flakes
- Lot/batch No.: pax 2068 rd 100
- Purity: 93.64 %
- Test Item arrived at Test Facility: 1998-11-25
- Storage conditions: desiccated at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN., USA
- Weight at study initiation: ranging from 2442 to 2915 g for males and 2426 to 2820 g for females
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow® #5322 (Purina Mills, Inc.), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C to 24°C
- Humidity: 33-49 %
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle

IN-LIFE DATES: From: 1999-02-01 To: 1999-03-17

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

deionized

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal trunk area, including the scapula to the wing of the ilium and halfway down the flank on each side of the animal.
- % coverage: approximately 10% of the body surface area
- Type of wrap if used: gauze dressing, a plastic wrap (occlusive binding) and an elastic wrap, secured around the trunk with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed using gauze moistened with deionized water followed by dry gauze.
- Time after start of exposure: approximately 24-hours

TEST MATERIAL
- Amount(s) applied:
Limit test I: dose level 2000 mg / kg bw; active dose level 1873 mg / kg bw
Limit test II: dose level 2136 mg / kg bw; active dose level 2000 mg / kg bw

- For solids, paste formed: yes

VEHICLE
- Amount(s) applied: 1 mL of deionized water / gram test item

Duration of exposure:

approximately 24-hours

Doses:

Limit test I: dose level 2000 mg / kg bw (active dose level 1873 mg / kg bw)
Limit test II: dose level 2136 mg / kg bw (active dose level 2000 mg / kg bw)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: following patch removal on study day 1 and daily thereafter (days 2-14)
weighing: prior to dosing on day 0 and on days 7 and 14

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Feces small in size, soft/mucoid stools, fecal stain and dark material around the facial area were observed during the study. Dermal irritation was noted at the site of test article application.

Gross pathology:

No significant gross internal findings were observed at necropsy on study day 14.