Allylamine

Endpoint summary

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

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 or test system 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:

other: 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

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 or test system 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 air

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

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 or test system 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:

other: 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