Heptylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Heptylamine

EC Number:

203-895-8

EC Name:

Heptylamine

Cas Number:

111-68-2

Molecular formula:

C7H17N

IUPAC Name:

heptan-1-amine

Details on test material:

- Name of test material (as cited in study report): MONO-n-HEPTYLAMINE (C7A)
- Physical state: colorless liquid
- Analytical purity: 99.51%
- Lot/batch No.: LABORATOIRE L 8602

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Credo, Les Oncins, 69210 L'Arbresle, France.
- Age at study initiation: 5 to 7 weeks old
- Weight at study initiation: 163-185g for males and 144-162 for females
- Fasting period before study: yes
- Housing: groups of 5 in stainless steel mesh cages
- Diet: Rat pelleted complete maintenance diet, ad libitum
- Water: Softened and filtered drinking water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 30-72
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

72, 104, 144mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality and abnormal clinical signs were noted 15 minutes after administration of the test article, then 1, 2 and 4 hours later and then daily for the 14 day study period
The animals were weighed on Day -1, Day (immediately before administration of the test article), Day 8 and Day 15. and at time of death from Day 2 onwards.
- Necropsy of survivors performed: yes

Statistics:

Bliss' method.

Results and discussion

Preliminary study:

5 groups composed of 2 males and 2 females each were treated at the dose levels of 64, 128, 256, 504 and 1000 mg/kg, mortalities were 25, 75, 100, 100 and 100%, respectively.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

74 mg/kg bw

Based on:

test mat.

95% CL:

49 - 110

Remarks on result:

other: Bliss' Method

Mortality:

0mg/kg: 0%
72mg/kg: 40%
104mg/kg: 90%
144mg/kg: 80%

Clinical signs:

other: 72mg/kg: dyspnea, sialorrhea in most rats with piloerection and prostration in some rats after 4 hours. On Day 2: piloerection, dyspnea and red coloration of the hair. On Day 10: all normal 104mg/kg: dyspnea with sialorrhea and convulsions in most surviv

Gross pathology:

Congestion of lungs and digestive tract.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

Migrated information

Conclusions:

LD50: 74mg/kg

Executive summary:

The Acute oral toxicity of mono-n-heptylamine was evaluated in male and female rats according to OECD N°401 guideline (Acute Toxic Standard Method) in compliance with principles of Good Laboratory Practices. Animals were treated and then observed for 14 days for mortality, clinical signs and effect on body weight. Under the experimental conditions, the LD50 of the test article administered as supplied, is equal to 74 mg/kg (49 - 110 mg/kg) according to BLISS'method and to 70 mg/kg (48 - 102 mg/kg) according to LITCHFIELD & WILCOXON's method.