Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 surviving rats within 15 minutes after treatment. Then prostration with piloerection, sialorrhea and/or dyspnea and ptosis in surviving rats until Day 6. On Day 4: one case of balloned abdomen.

144mg/kg: dyspnea and sialorrhea in all rats just after treatment. Then prostration with piloerection and in some cases dyspnea and sialorrhea in the next hours. On Days 2 to 6: prostration, piloerection with dyspnea on Day 6.
Body weight:
See attached table
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.