N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30.01.2015 to 30.10.2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

EC Number:

252-899-6

EC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Cas Number:

36177-92-1

Molecular formula:

C13H28N2

IUPAC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: CRL:(WI) rats
- Weight at study initiation: males 226-243 g, females 209-247 g
- Housing: individual caging in Type II cages (polypropylene/polycarbonate)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9-24.8
- Humidity (%): 37-50
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24-hour exposure period. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi-occlusive plastic wrap for 24 hours.

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male
5 female

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Administration of the test item led to the death of 10/10 animals at the dose level of 2000 mg/kg bw. Seven out of ten animals were found dead, and 3/10 animals were in moribund status at the observation 24 hours post application. Moribund animals were euthanized for animal welfare reason after consultation with the Clinical Veterinary.

Clinical signs:

other: At 5 hours post application, animals were symptom free. At 24 hours post application, 4 male, 3 female animals were found dead and 1 male, 2 female animals were in a moribund status (verified by the Clinical Veterinary). During the assessment of the gener

Gross pathology:

A single 24-hour dermal application of N-Butyl-TAD to CRL:(WI) rats at a dose level of 2000 mg/kg bw led to the preterminal euthanasia (three rats) or death (seven rats) on Day 1. Test item-related black diffuse discoloration of the skin (external examination) and red-black diffuse discoloration of the skin (internal examination) were observed at the sites of application. Dark/red discoloration of the collapsed/non-collapsed lungs were typical for found dead animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The application of the test item at 2000 mg/kg bw caused extremely severe local dermal signs and led to the death of 10/10 animals (7 dead, 3 euthanized). The acute dermal median lethal dose (LD50) of the test item N-Butyl-TAD was found to be lower than 2000 mg/kg bw in male and female CRL:(WI) rats in a limit test. Due to the corrosive potential of the test item, a full test was not performed for animal welfare reasons.