1-methylpiperidine

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 guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-methylpiperidine

EC Number:

210-959-9

EC Name:

1-methylpiperidine

Cas Number:

626-67-5

Molecular formula:

C6H13N

IUPAC Name:

1-methylpiperidine

Details on test material:

- Name of test material (as cited in study report): 1-Methylpiperidine
- Physical state: liquid, clear to yellow
- Analytical purity: 99.6 %
- Lot/batch No.: #30315AC
- Storage condition of test material: 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: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: Young adults
- Weight at study initiation: males: 2.2 - 2.8 kg; females: 2.2 - 2.6 kg
- Housing: singly
- Diet: Pelleted Purina Rabbit Chow, ad libitum.
- Water: Filtered tap water was supplied by automatic water system, ad libitum.
- Acclimation period: 10 or 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: of approximately 4x6"
- % coverage: approximately 10% of the body surface
- Type of wrap if used: covered with one or two adhesive backed-gauze patches. The patches and entire trunk of each animal were then wrapped with 3" Durapore tape to avoid dislocation of the patches and to minimize evaporation of the test substance. Elizabethan collars were placed on each rabbit and they were returned to their designated cage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the patches and collars were removed and the test sites gently wiped with water and a clean towel to remove any residual test substance.
- Time after start of exposure: 24 hours

Duration of exposure:

24 h

Doses:

100, 300 and 1000 mg/kg bw.
preliminary study: 2000 mg/kg bw.

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 for signs of gross toxicity, behavioral changes and mortality: at least once daily.
- Frequency of weighing: prior to application and on days 7 and 14 (termination).
- Necropsy of survivors performed: yes, rabbits were euthanized via sodium pentobarbital injection on day 14. A gross necropsy was performed on all animals at terminal sacrifice. Tissues and organs of the thoracic and abdominal cavities were examined.
- Other examinations performed: gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, sleep and coma.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: At 1000 mg/kg bw 0/10 animals died. At 2000 mg/kg bw 2/2 animals died.

Mortality:

100, 300 and 1000 mg/kg bw: no mortality (0/5 males and 0/5 females died, respectively)
2000 mg/kg bw: 2/2 died

Clinical signs:

other: Transient conditions related to laxation were noted in several animals during the study. 100 mg/kg: One male and one female exhibited soft feces between 1 and 4.5 hours after test substance application. Apart from severe dermal irritation at the dose site

Gross pathology:

Gross necropsy findings at terminal sacrifice were unremarkable; all tissues and organs appeared normal.

Other findings:

Severe dermal irritation including eschar was noted at the application site of all animals.

Any other information on results incl. tables

Table 1 Body weight.

 

Dose [mg/kg bw]	Body weight (mean ± SD) [kg]
	initial	7 days	14 days
Males
100	2.62 ± 0.12	2.80 ± 0.12	2.94 ± 0.11
300	2.42 ± 0.19	2.56 ± 0.18	2.68 ± 0.31
1000	2.56 ± 0.11	2.66 ± 0.11	2.84 ± 0.09
Females
100	2.42 ± 0.15	2.68 ± 0.13	2.80 ± 0.07
300	2.42 ± 0.08	2.52 ± 0.13	2.72 ± 0.13
1000	2.32 ± 0.11	2.46 ± 0.09	2.66 ± 0.09