2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study

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 402 (Acute Dermal Toxicity)

Version / remarks:

(February 24, 1987)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(Bioassay Labor für biologische Analytik,GmbH, Heidelberg)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethylpiperidin-4-yl dodecanoate

EC Number:

700-503-1

Cas Number:

101238-01-1

Molecular formula:

C21 H41 N O2

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-yl dodecanoate

Details on test material:

- Analytical purity: 94%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: male animals approx.8 weeks, female animals approx. 12 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
- % coverage: at least 10% of the body surface
- Type of wrap if used: The test item was covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.24 mL/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality and no adverse findings upon necropsy occurred. Local irritation was observed.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. Skin effects at the application site comprised well-defined erythema (grade 2) in all male animals 1 day after application which persisted in one animal until study day 2. This animal s

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Any other information on results incl. tables

Table 1: BODY WEIGHTS
Dose (mg/kg bw):	2000
Sex:	male
Administration:	1
Animal No.:	1	2	3	4	5	Mean weight	Standard deviation
Body weight at study day (g):
0	245	238	225	240	238	237,2	7,4
7	256	257	241	272	256	256,4	10,97
14	292	283	265	300	290	286	13,21
Dose (mg/kg bw):	2000
Sex:	female
Administration:	1
Animal No.:	1	2	3	4	5	Mean weight	Standard deviation
Body weight at study day (g):
0	210	200	204	206	201	204,2	4,02
7	212	200	209	205	197	204,6	6,19
14	228	209	216	213	203	213,8	9,31

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU