Isopentylamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 403).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopentylamine

EC Number:

203-526-0

EC Name:

Isopentylamine

Cas Number:

107-85-7

Molecular formula:

C5H13N

IUPAC Name:

isopentylamine

Details on test material:

- Name of test material (as cited in study report): Isopentylamin
- Physical state: liquid / colorless
- Analytical purity: 99.7 %
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 266±10.8 g; female: 183±7.8 g (mean).
- Housing: 5 animals/cage
- Diet: tap water, ad libitum
- Water: KLIBA rat/mouse laboratory diet 24-343-4, 10 mm pellets, Klingentalmühle AG, Switzerland, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gas chromatographical method

Duration of exposure:

4 h

Concentrations:

5.2 mg/L, 9.9 mg/L, 17.4 mg/L

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

11.5 mg/L air

95% CL:

6.4 - 52.3

Exp. duration:

4 h

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

8.5 mg/L air

Exp. duration:

4 h

Effect levels 3

Sex:

female

Dose descriptor:

LC50

Effect level:

13.7 mg/L air

Exp. duration:

4 h

Mortality:

17.4 mg/L: 4 males and 1 female died on the day of exposure. 3 females died on day 1 after exposure.
9.9 mg/L: 2 males and 2 females died on the day of exposure.
5.2 mg/L: 2 males died on the day of exposure.

Clinical signs:

other: During exposure: 5.2 mg/L. escape attempts, restlessnes, eyelid closure, irregular respiration, accelerated respiration, reddish nasal discharge, intermittend respiration. 9.9 mg/L: escape attempts, eyelid closure, irregular respiration, accelerated respi

Body weight:

The body weight gain of male and female rats compared with a historical control collective, was retarded to reduced in the first week of the observation period and adjusted to normal in the second week of the observation period.

Gross pathology:

Animals that died:
5.2 mg/L: general congestion, moderate, focal hyperemia of the lungs.
9.9 mg/L: general congestion.
17.4 mg/L: general congestion, moderate, intensified hyperemia of the lungs.

Any other information on results incl. tables

Mortality:

Dose (mg/L)	Gender	day 0	day 1	day 2	day 7	day 14
5.2	male	2/5	2/5	2/5	2/5	2/5
5.2	female	0/5	0/5	0/5	0/5	0/5
9.9	male	2/5	2/5	2/5	2/5	2/5
9.9	female	2/5	2/5	2/5	2/5	2/5
17.4	male	4/5	4/5	4/5	4/5	4/5
17.4	female	1/5	3/5	3/5	3/5	3/5

Weight (g):

Dose (mg/L)	Gender	day 0	day 7	day 13
5.2	male	275	273	315
5.2	female	179	189	208
9.9	male	260	260	295
9.9	female	182	191	209
17.4	male	264	262	318
17.4	female	188	155	196

There is indication that the test substance causes local irritation to the exposed tissue including respiratory tract.

Harmful if inhaled.

Applicant's summary and conclusion

Conclusions:

The combined male and female LC50(rat, 4 hr)was 11.5 mg/L. Local irritation (includes respiratory tract) was considered to cause toxicity and mortality

Executive summary:

The acute inhalation toxicity of isopentylamine was examined in male and female rats (n=5 per sex and dose) that were exposed to isopentylamine (duration 4 hours; 5.2, 9.9, and 17.4 mg/L; analytical monitoring) in a guideline study under GLP conditions. The observation period was 14 days.

Signs of eye and respiratory irritation were seen during exposure at all concentrations. Mortalities occurred at all dose levels on the day of exposure. Body weight of survivors was reduced in the first week after treatment, but was comparable to historical controls at the end of the second week. Gross pathology revealed general congestion and hyperemia of the lungs at all dose levels. The combined male and female LC_{50(rat, 4 hr)}was 11.5 mg isopentylamine/L (11,500 mg/m³) in this study. Local irritation (includes respiratory tract) was considered to cause toxicity and mortality (BASF, 1989).