Registration Dossier

Administrative data

Description of key information

Oral LD50 = 57 mg/kg bw in mice (Hine, CH et al, 1960)

Inhalation LC50  = 413 mg/m3, 8 hours in rats (Hine, CH et al, 1960)

Dermal LD50 = 35 mg/kg in rats (Hine, CH et al, 1960)

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:
supporting study
Study period:
1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Old study, not to GLP, but similar to current guidelines
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Old study
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
other: Princeton
Sex:
male
Details on test animals and environmental conditions:
Animals weighed 13-22g
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): Varies with dose level
- Justification for choice of vehicle: Not stated
- Lot/batch no. (if required):
- Purity:
Doses:
20, 40, 80 and 160 mg/kg.
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes, where possible
Statistics:
LD50 calculated by method of Weil, 1952.
Preliminary study:
Not applicable
Sex:
male
Dose descriptor:
LD50
Effect level:
57 mg/kg bw
Based on:
test mat.
Mortality:
20 mg/kg: 0/5
40 mg/kg: 0/5
80 mg/kg: 5/5 (4-8 hours)
160 mg/kg: 5/5 (2-4 hours)
Clinical signs:
None seen
Gross pathology:
Mice that died had congestion of the gastroenteric tract, discoloured livers, pale spleens, and hyperemic lungs, but histologically all tissues were within normal limits. No findings among survivors.
Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was 57 mg/kg
Executive summary:

Mortality in male mice was:

20 mg/kg: 0/5

40 mg/kg: 0/5

80 mg/kg: 5/5 (4-8 hours)

160 mg/kg: 5/5 (2-4 hours)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
57 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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Old study, not to GLP, but similar to current guidelines
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
only males tested
GLP compliance:
no
Remarks:
Old study
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Long-Evans
Sex:
male
Details on test animals and environmental conditions:
Animals weighed 120-160 g
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: whole body
- Exposure chamber volume: 19.5L
- Method of holding animals in test chamber: not stated
- Source and rate of air:7.0-9.5 L/min (source not stated)
- Method of conditioning air: not stated
- System of generating vapour: air passing over evaporator
- Treatment of exhaust air: not stated
- Temperature, humidity, pressure in air chamber: not stated

TEST ATMOSPHERE
- Brief description of analytical method used: by theoretical calculation

Analytical verification of test atmosphere concentrations:
no
Remarks:
but concentrations calculated
Duration of exposure:
8 h
Concentrations:
89, 133, 200 and 300 ppm
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes, where possible
Statistics:
LC50 calculated by method of Weil, 1952.
Preliminary study:
Not applicable
Sex:
male
Dose descriptor:
LC50
Effect level:
177 ppm
95% CL:
151 - 209
Exp. duration:
8 h
Mortality:
89 ppm: 0/5
133 ppm: 0/5
200 ppm: 4/5 (8-24 hours)
300 ppm: 5/5 (8-24 hours)
Clinical signs:
other: At all concentrations, allylamine was irritating to the eye and upper respiratory tract as indicated by face-washing motions. Lacrimation and nasal discharge followed at higher levels. A few rats showed severe air hunger, with gasping, at the highest co
Gross pathology:
The stomachs of rats that died were greatly distended with air, and the lungs contained fluid. Those surviving as long as 3 hours had haemorrhage into the alveolar spaces and acute pulmonary oedema. No gross or microscopic abnormalities were observbed among survivors.
Interpretation of results:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 8 hour LC50 of allylamine was 177 (151-209) ppm
Executive summary:

Mortality of male rats after 8 hours exposure to allylamine was:

89 ppm: 0/5

133 ppm: 0/5

200 ppm: 4/5 (8 -24 hours)

300 ppm: 5/5 (8-24 hours)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
413.29 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Old study, not to GLP, but similar to current guidelines
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 3 animals per dose
GLP compliance:
no
Remarks:
Old study
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Animals weighed 2.0-2.8 kg
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back/flanks
- % coverage: Not stated
- Type of wrap if used: rubber
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped dry
- Time after start of exposure: several hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): neat material, as required
- Concentration (if solution): N/A

Duration of exposure:
Several hours
Doses:
13, 25, 50 and 100 mg/kg
No. of animals per sex per dose:
3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes, where possible
Statistics:
LD50 calculated by method of Weil, 1952.
Preliminary study:
Not applicable
Sex:
male
Dose descriptor:
LD50
Effect level:
35 mg/kg bw
Based on:
test mat.
Mortality:
13 mg/kg: 0/3
25 mg/kg: 0/3
50 mg/kg: 3/3 (4-24 hours)
100 mg/kg: (3-4 hours)
Clinical signs:
Considerable local erythema and oedema, progressing to eschar formation

Deaths occurred with no preliminary sign but head drop
Gross pathology:
Premature decedents usually had fluid in the pleural cavity and dilation of the gastroenteric veins. Microscopically all had severely congested lungs.
Interpretation of results:
Toxicity Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was 35 mg/kg
Executive summary:

Mortality in male rabbits was:

13 mg/kg: 0/3

25 mg/kg: 0/3

50 mg/kg: 3/3 (4-24 hours)

100 mg/kg: (3-4 hours)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
35 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Lower LD50 of 2 species; studies of equal validity

Justification for selection of acute toxicity – inhalation endpoint
Lowest LC50, based on longest exposure period

Justification for selection of acute toxicity – dermal endpoint
Only study available

Justification for classification or non-classification

In accordance with Regulation (EC) No 1272/2008 (CLP) the following acute toxicity classifications are applied:

Acute oral toxicity: Category 3

Acute inhalation toxicity: Category 2

Acute dermal toxicity: Category 1