sec-butylamine

Endpoint summary

Description of key information

There are one acute oral toxicity study, one acute inhalation toxicity study and one acute dermal toxicity study.

1- The LD 50 values (mg/kg body wt) for oral toxicity were for male, 157.5 mg/kg and for female, 146.8 mg/kg.

2 -The LC 50 was set at 11.2 mg/l (3680 ppm).

3 -The LD 50 for acute dermal toxicity was: LD 50: 200-2000 mg/kg/day

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

other: public study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Principles of method if other than guideline:

Male and female weanling Sprague-Dawley CD rats
of the same age were obtained from the Charles River
Breeding Laboratories, Wilmington, Massachusetts.
These animais were housed two per cage and were acclimated
to laboratory conditions for 2 weeks prior to
initiation of the experiment. Laboratory temperatures
ranged from 22 to 26°C, and the relative humidity
ranged from 22 to 49%. A 12-hr light-dark schedulewas maintained with the light cycle beginning at 7:00
AM. Except for an 18-hr period immediately prior to
treatment, the animais were provided with Rodent Laboratory
Chow (Ralston Purina Co., St. Louis, Mo.). Tap
water was available ad libitum.
In a range-finding study, rats were treated in groups
of two males and two females with various amounts of
the test compound. From the resulting mortality data,
a range of doses was
established. Solutions of the monobutylamines were
then prepared in corn oil such that doses of 1 OO, 200,
300, 400, 500, and 600 mg/kg body wt for sec.-butylamine,
could be administered in a constant 4-ml volume.
Upon initiation of the toxicity experiment, the rats
were starved overnight, weighed (males, 194. 7 ± 20. 5
g; females, 156 ± 16.8 g), and randomly assigned to 24
dosage groups, each group consisting of 10 male and 10
female rats. The specified doses of each monobutylamine
were administered, by gavage, to ail rats within the corresponding
dosage groups. These animais were observed
for signs of toxicity or mortality during the subsequent
14-day period, and those that died during this period
were subjected to gross pathological examination. LD,0
values for each monobutylamine were calculated for
both niales and females from the mortality in the several
groups by the probit method of Finney ( 1971 ).

GLP compliance:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

These animais were observed
for signs of toxicity or mortality during the subsequent
14-day period, and those that died during this period
were subjected to gross pathological examination. LD,0
values for each monobutylamine were calculated for
both niales and females from the mortality in the several
groups by the probit method of Finney ( 1971 ).

Doses:

1 OO, 200,300, 400, 500, and 600 mg/kg body wt for sec.-butylamine

No. of animals per sex per dose:

2 males and 2 females

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

157.5 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

146.8 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

152.4 mg/kg bw

Based on:

test mat.

Mortality:

sedation, ataxia, nasal
discharge, gasping, salivation, and, at higher
doses, convulsions and death. At the dose
levels tested, death generally occurred within
1 to 3 hr after administration of the amine.
Animais which survived the 14-day period
appeared normal and were not further examined.
Gross pathological examination of
animais that died following treatment showed pulmonary edema

Clinical signs:

other: sedation, ataxia, nasal discharge, gasping, salivation, and, at higher doses, convulsions and death. At the dose levels tested, death generally occurred within 1 to 3 hr after administration of the amine. Animais which survived the 14-day period appeared

sec.-Butylamine              LD (50)                                          slope (+/_ SD)

M                               157.5 ( 35.1 -242.8)                            1.89 (±0.67)

F                              146.8 (12.4-239.3)                           1.67 (±0.66)

M and F                        152.4 (69.3-214.8)                          1.78 (±0.47)

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Sec butylamine is toxic after oral ingestion in rats.

Executive summary:

The LD50 values for the substance was calculated by the probit method.

No significant sex-related differences were noted. The 14-day, po single-dose

LD50 values (mg/kg body wt) were: for male, 157.5 mg/kg, and for female, 146.8 mg/kg.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

157.5 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

mouse

Strain:

other: WBS/S

Details on test animals or test system and environmental conditions:

5 MALES OF wbs/s MICE 527+/- g BW) were placed in each of a series of 20-liter exposure chambers and the latter sealed airtight. A measured volume of the sample was then injected upon a disc of filter paper suspended in each chamber. (The sample was seen to evaporate completely within 20 seconds). The mice were observed continuously during an exposure period of one hour and suviving animals were observed for 11 days.

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

5 MALES OF wbs/s MICE 527+/- g BW) were placed in each of a series of 20-litter exposure chambers and the latter sealed airtight. A measured volume of the sample was then injected upon a disc of filter paper suspended in each chamber. (The sample was seen to evaporate completely within 20 seconds). The mice were observed continuously during an exposure period of one hour and suviving animals were observed for 11 days.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

1 h

Concentrations:

8, 10, 12.5, 16, 20 and 25 mg/l

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

5 MALES OF wbs/s MICE 527+/- g BW) were placed in each of a series of 20-litter exposure chambers and the latter sealed airtight. A measured volume of the sample was then injected upon a disc of filter paper suspended in each chamber. (The sample was seen to evaporate completely within 20 seconds). The mice were observed continuously during an exposure period of one hour and suviving animals were observed for 11 days.

Statistics:

none

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

11.2 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

0 % mortality at 8 mg/L
20% mortality at 10 mg/l
80% mortality at 12.5 mg/L
100% mortality at 16 mg/L
100% mortality at 20 mg/l
100% mortality at 25 mg/l

Clinical signs:

other: severe sensory irritation, dffrantic escape activity, salivation and bronchospastic gasping.

Body weight:

not recorded

Gross pathology:

not examined

Interpretation of results:

Category 3 based on GHS criteria

Executive summary:

5 males of wbs/s MICE 527+/- g BW were placed in each of a series of 20-litter exposure chambers and the latter sealed airtight. A measured volume of the sample was then injected upon a disc of filter paper suspended in each chamber. (The sample was seen to evaporate completely within 20 seconds). The mice were observed continuously during an exposure period of one hour and suviving animals were observed for 11 days. The LC 50 was set at 11.2 mg/l (3680 ppm).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

11 200 mg/m³ air

Quality of whole database:

Old study comparable to guideline.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

male

Type of coverage:

occlusive

Vehicle:

other: 200 mg/kg (10% aqueous solution) and 2000 mg/kg pure

Duration of exposure:

24hours

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

6 males/rats

Control animals:

no

Details on study design:

Doses were applied to the hair-clipped skin of the trunk under an occluding sleeve on each animal. The sleeves were removed 24 hours later and survivors were observed for 7 days.

Statistics:

none

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

At 2000 mg/kg: contact with the undiluted sample caused pain. Erythema appeared immediately and then became black within 10 minutes. 2 of 3 rats dies overnight (>3 hours). Large areas of skin were completely destroyed in each of the animals.

Clinical signs:

other: not recorded.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

LD 50: 200-2000 mg/kg/day

Executive summary:

Three rats were treated dermally with 2000 mg/kg and three were treated with 200 mg/kg (10% aqueous solution). Doses were applied to the hair clipped skin of the trunk under an occluding sleeve on each animal.The sleeves were removed 24 hours later and survivors were observed for seven days.

2000 mg/kg : contact with the undiluted sample caused pain appeared immediately and then became black within ten minutes.Two of the three rats died overnight (>3hours). Large areas of skin were completely destroyed in each of the animals.

200 mg/kg: contact with 10% dilution also caused pain. Erythema appeared within one minute and persisted without further change. None of the rats died. Scattered scabs were formed on each animal.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

200 mg/kg bw

Quality of whole database:

Old study comparable to guideline

Justification for classification or non-classification

Proposed classification according to Regulation EC 1272/2008

Oral route: cat 3; hazard label H 301

Inhalation: cat 3; hazard label H 331

Dermal: cat 3; Hazard label H311