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Diss Factsheets

Administrative data

Description of key information

Octylamine is harmful if swallowed (oral , rat : LD50 < 200 mg/kg bw ) or inhaled (LC50(rat, 4 hr) :1.6 mg/L ). The LD50 (dermal, rabbit) was between 200 mg/kg bw and 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The test substance was administered orally at a dose level of 200 mg/kg bw to 5 male and 5 female rats. The animals were then observed for 21 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Age at study initiation: young adults
- Weight at study initiation: mean males: 191 g; mean females: 179 g
- Fasting period before study: the animals were given no feed about 16 hours before administration
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.26 ml/kg
Doses:
200 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration and at least once each workday; Check for moribund and dead animals twice each workday and once on holidays. Weighing was performed on day 0, day 6, day 13, day 20.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 200 mg/kg bw
Mortality:
2/5 male animals and 5/5 female animals died
Clinical signs:
other: male animals: poor general state, dyspnoea, apathy, staggering, piloerection, exsiccosis, salivation, weight reduction, discoloured urine (red) female animals: poor general state, dyspnoea, apathy, staggering, piloerection, smeared fur, exsiccosis, weight
Gross pathology:
animals that died: general congestion
lungs: intensified emphysema in one animal, emaciation in two animals; these two animals died after 10 and 20 days.
sacrificed animals:
no pathologic findings noted

Mortality

 Dose (mg/kg)  No. of animals  Died within1h  1 day  2 days  7 days  14 days  21 days
 200 5 male   0  1  1  1  1  2
 200  5 female  2  4  4  4  4  5

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of n-octylamine was determined to be below 200 mg/kg.
Executive summary:

In a non-GLP study that was conducted similar to OECD TG 401, n-octylamine was administered at 200 mg/kg bw by oral gavage to male and female rats (5 animals per sex and dose) that were fasted 16 h before administration. Signs of toxicity included poor general state, dyspnoea, apathy, staggering, piloerection, exsiccosis, salivation, weight reduction, discoloured urine (red), smeared fur, and snout red crusted. At 200 mg/kg bw, 2/5 male animals and 5/5 female animals died. Gross lesions of the animals that died included general congestion, intensified emphysema (one animal), and emaciation (two animals) of the lungs. The acute oral LD50 in rats was below 200 mg/kg bw (BASF, 1990).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
200 mg/kg bw
Quality of whole database:
good quality, guideline studies available, result supported by several studies

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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Rats (10/sex/dose) were exposed to an aerosol (seven different doses) of the test substance (head/nose exposure) for 4 hours. The rats were then observed for 14 days and the LC50 was calculated.
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: WIGA, Sulzfeld and MUS RATTUS, Brunnthal
- Weight at study initiation: 185 +- 15 g
- Diet: ad libitum
- Water: ad libitum
no further data

ENVIRONMENTAL CONDITIONS
no data
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
continuous infusion pump UNITA (B. Braun), two substance injector (Rhema Jato)
The test substance was fed in a constant amount using a continuous infusion pump into a two substance injector. Compressed air (up to 3 bar) was
used to generate ab aerosol which was then fed into the exposure chamber. The pressure in the inhalation system was adjusted to 3 Pa to generate
over pressure.


TEST ATMOSPHERE
- Brief description of analytical method used: the atmosphere in the exposure chamber was analyzed using gas chromatography
- Samples taken from breathing zone: yes

no further data
Analytical verification of test atmosphere concentrations:
yes
Remarks:
using gas chromatography
Duration of exposure:
4 h
Concentrations:
0.13, 0.76, 1.44, 1.57, 1.64, 2.58, 9.85 mg/l (analytical concentration)
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed daily, weighing on day 0, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross patholody
Statistics:
Probitanalysis according to D.J. Finney in the BASF computing center
Sex:
male/female
Dose descriptor:
LC50
Effect level:
1.6 mg/L air
Exp. duration:
4 h
Mortality:
4 hour exposure:
at 0.13 mg/l 0/10 male and 0/10 female rats died; at 0.76 mg/l 1/10 male and 0/10 female rats died; at 1.44 mg/l 4/10 male and 1/10 female animals died; at 1.57 mg/l 3/10 male and 1/10 female animals died; at 1.64 mg/l 5/10 male and 7/10 female animals died; at 2.58 mg/l 9/10 male and 10/10 female animals died; at 9.85 mg/l 10/10 male and 10/10 female animals died
Clinical signs:
other: 0.13 mg/l dose group: aqueous to reddish secretion from the eyes and nose, animals were free of signs of toxicity after 2 days 0.76-2.58 mg/l dose group: attempts to escape, aqueous to reddish secretion from the eyes and nose, eye lid closure, intermitten
Body weight:
There were no significant changes in weight gain in most dose groups, most animals gained weight normally.
Male rats of the 1.44 mg/l dose group showed a reduced weight gains compared to controls and the surviving male animal of the 2.58 mg/l dose group also showed a reduced weight gain.
Gross pathology:
animals that died:
heart: acute dilation of the antechambers, acute congestive hyperemia
lung: striking hyperemia, oedematous

sacrificed animals: organs without findings
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test the LC50 in rats was 1.6 mg/L.
Executive summary:

Sprague-Dawley rats (10 animals per sex and dose) were exposed against 0, 0.13, 0.76, 1.44, 1.57, 1.64, 2.58, 9.85 mg substance/l (analytical concentration) for 4 h (nose only exposure). The animals were observed for 14 days.

at 0.13 mg/l 0/10 male and 0/10 female rats died; at 0.76 mg/l 1/10 male and 0/10 female rats died; at 1.44 mg/l 4/10 male and 1/10 female animals died; at 1.57 mg/l 3/10 male and 1/10 female animals died; at 1.64 mg/l 5/10 male and 7/10 female animals died; at 2.58 mg/l 9/10 male and 10/10 female animals died; at 9.85 mg/l 10/10 male and 10/10 female animals died. The LC50 in rats was dertermined with 1.6 mg/L.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
1 600 mg/m³ air
Quality of whole database:
sufficient quality, key study similar 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:
other: Comparable to guideline study with acceptable restrictions ( observation period 7 days; limited documentation, i.e. no details reported (location; size of treated area; exposure duration; washing etc.)
Principles of method if other than guideline:
Method: three dose levels tested, observation period 7 days; however, no details reported (location; size of treated area; exposure duration; washing)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-85°F
Type of coverage:
not specified
Vehicle:
other: none
Details on dermal exposure:
Project No. 6006-85
Protocal No. C22/AO-MSDS
Duration of exposure:
no data
Doses:
200, 2000, and 3000 mg/kg bw
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 17 days
Statistics:
none
Sex:
not specified
Dose descriptor:
LD0
Effect level:
200 mg/kg bw
Sex:
not specified
Dose descriptor:
LD100
Effect level:
2 000 mg/kg bw
Mortality:
Within 7 days no deaths (0/4) at 200 mg/kg bw; all animals dead at 2000 mg/kg bw (4/4, within 2 days) and at 3000 mg/kg bw (4/4, within 1 day)
Clinical signs:
other: At 200 mg/kg, dermal necrosis At the high doses, hypoactivity and prostration prior to death


MORTALITY:

 200 mg/kg bw: 0/4 animals
2000 mg/kg bw: 4/4 animals
3000 mg/kg bw: 4/4 animals
  
CLINICAL SIGNS:
At 200 mg/kg, dermal necrosis
At the high doses, hypoactivity and prostration

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 (rabbit): 200 mg/kg bw
Executive summary:

The dermal toxicity of n-octylamine was tested in rabbits (4 animals per dose) at 200, 2000, and 3000 mg/kg bw. The observation period was 7 days, other methodological details were not reported. However, the study is regarded to be reliable with restrictions.

All animals at 3000 and 2000 mg/kg bw died within one or two days, respectively. There were no deaths within 7 days after treatment in rabbits receiving 200 mg/kg bw but dermal necrosis at the test sites. The LD50 (dermal, rabbit) was therefore higher than 200 mg/kg bw and less than 2000 mg/kg bw (Biodynamics, 1985).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
201 mg/kg bw
Quality of whole database:
sufficient quality, key study similar to guideline

Additional information

Oral toxicity:

The estimated oral LD 50 in rat was below 200 mg/kg bw in Key study (BASF, 1990)

In a non-GLP study that was conducted similar to OECD TG 401, n-octylamine was administered at 200 mg/kg bw by oral gavage to male and female rats (5 animals per sex and dose) that were fasted 16 h before administration. Signs of toxicity included poor general state, dyspnoea, apathy, staggering, piloerection, exsiccosis, salivation, weight reduction, discoloured urine (red), smeared fur, and snout red crusted. At 200 mg/kg bw, 2/5 male animals and 5/5 female animals died. Gross lesions of the animals that died included general congestion, intensified emphysema (one animal), and emaciation (two animals) of the lungs. The acute oral LD50 in rats was below 200 mg/kg bw (BASF, 1990).

Following a pretests using 2 animals of either sex, octylamine was administered at 250 mg/kg bw by oral gavage to male and female rats that were fasted overnight in a limit test (GLP, similar to OECD TG 401). Clinical signs observed during the first 8 days postdose included salivation, breathing abnormalities, decreased activity, dark material around the facial area, decreased defecation, rough hair, urine stains, and dehydration. Males gained body weight during the study, whereas females lost weight. There were 2 mortalities in the female group during the 14-day observation period. Necropsy revealed signs of local irritation in survivors (thickened mucosa of the nonglandular stomach and reduced body fat) and in animals that died (colored mucoid contents in the digestive tract, and black foci on the stomach). As mortality was low (2/10 animals died), it was concluded that the LD50-value is >250 mg/kg bw (Springborn, 1990).

In a non-GLP study that was conducted similar to OECD TG 401, octylamine was administered at 50, 108, 232, 500, and 1076 mg/kg bw by oral gavage to male and female rats (5 animals per sex and dose) that were fasted overnight. The doses were selected based on the results of a preliminary study using 1 rat per sex and dose, at dose levels from 25 to 500 mg/kg bw. In the main study, all animals at 50 and 108 mg/kg bw survived. Signs of toxicity included piloerection and reduced activity which subdued within 24 hours. At 232 mg/kg bw, one female died. Clinical signs at this dose level (piloerection and slight tremors) subsided within 48 hours after treatment. All animals at 500 and 1076 mg/kg bw died. All deaths occurred within 30 to 60 minutes after dosing. The acute oral LD50 in rats was 315 mg/kg bw (Safepharm, 1980).

Two non-reliable studies (BASF, 1976 and Hoechst 1986) determined LD50 values of 783 mg/kg bw or 200 - 500 mg/kg bw respectively.

Overall, the analysis shows, that apart from the key study all studies showed LD50 values above 200 mg/kg bw.In the key study an LD50 value of < 200 mg/kg bw was determined. It can be concluded that an oral LD50 value below 50 mg/kg bw is highly unlikely.

Inhalation:

Sprague-Dawley rats (10 rats per sex and dose) were exposed to n-octylamine at 0.13, 0.76, 1.44, 1.57, 1.64, 2.58, and 9.85 mg/L (analytical concentrations; aerosol/vapor; head-only exposure, duration 4 hours) in a valid non-GLP pre-guideline study that was basically similar to OECD TG 403. Lacrimation and nasal discharge but no mortality was seen at 0.13 mg/L until 1 day after treatment. Dyspnea, trembling, unsteady gait, rough fur, hunched posture and corneal opacity were seen in a dose-dependent manner in groups at 0.76 – 9.85 mg/L. Deaths occurred during exposure in the highest dose group, and on the day of treatment in all other groups. Necropsy revealed acute atria dilatation and hyperemic, edematous lungs in animals that died, but no particular findings in animals that survived. The combined male and female LC50(rat, 4 hr) was 1.6 mg/L (BASF, 1979).

Dermal toxicity:

The dermal toxicity of n-octylamine was tested in rabbits (4 animals per dose) at 200, 2000, and 3000 mg/kg bw. The observation period was 7 days, other methodological details were not reported. However, the study is regarded to be reliable with restrictions.

All animals at 3000 and 2000 mg/kg bw died within one or two days, respectively. There were no deaths within 7 days after treatment in rabbits receiving 200 mg/kg bw but dermal necrosis at the test sites. The LD50 (dermal, rabbit) was therefore higher than 200 mg/kg bw and less than 2000 mg/kg bw (Biodynamics, 1985).

In a non-GLP study with 10 rabbits (5 males and 5 females) no animal died after dermal application of 200 mg/kg bw (24 h occlusive) during the 8 days observation period. The animals showed necrosis at the application site. This study supports the finding that the dermal LD50 is > 200 mg/kg bw (BASF AG, 1979).


Justification for selection of acute toxicity – oral endpoint
reliable guideline study, lowest LD50 observed in different studies

Justification for selection of acute toxicity – inhalation endpoint
reliable study, similar to guideline

Justification for selection of acute toxicity – dermal endpoint
reliable study, similar to guideline

Justification for classification or non-classification

According to the criteria set in Regulation (EC) No 1272/2008 a classification for acute oral and dermal toxicity Category 3 and acute inhalation toxicity Category 4 is required as available data indicate that oral LD50 is below 200 mg/kg bw, dermal LD50 is between 200 and 2000 mg/kg bw and the inhalation LC50 is 1.6 mL/L.