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Description of key information

Acute oral toxicity

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 (Guillot, 1990). 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.

Acute dermal toxicity

The potential acute toxicity of the test substance n-HEPTYLAMINE was evaluated in rats according to the recommendations of the O.E.C.D. Guideline No. 402 (O.E.C.D., 24th February 1987) administered by dermal route and the Principles of Good Laboratory Practice (O.E.C.D., 12th May 1981) (Clouzeau, 1992). The test substance was applied in its original form directly to the skin of 10 Sprague-Dawley rats (5 males and 5 females) at a dose level of 2000 mg/kg, taking into consideration that the specific gravity (SG) of the test substance was 0.773. After 24 hours under a semi-occlusive dressing, no residual test substance was observed at removal of the dressing. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days after the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study. No clinical signs were observed after application of the test substance. Between days 2 and 15, signs of necrosis of the skin without tissular lesions on the whole depth of the skin were observed on the area receiving the test substance. Between days 2 and 5, the body weight gain of the females slowed down and that of the males was reduced by 5 g. The body weight gain of all animals returned to normal thereafter. No deaths occurred at the dose level of 2000 mg/kg. Under our experimental conditions, the LD0 of the test substance n-HEPTYLAMINE when administered by dermal route in rats was higher than 2000 ng/kg.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reference:
Composition 0
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 information:
Composition 1
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
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.
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
74 mg/kg bw
Quality of whole database:
GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: mean body weight of 279 ± 10 g for the males and 225 ± 2 g for the females
- Fasting period before study: no
- Housing: The animals were housed in groups of 4 to 7 animals of the same sex per cage during the acclimatization period and individually during the study. They were housed in polycarbona te cages ( 48 x 27 x 20 cm) during the acclimatization period, and (35.5 x 23.5 x 19.3 cm) throughout the study.
- Diet: fed ad libitum with a certified pelleted diet "Rats - Mice sustenance ref. A04 C"
- Water: free access to tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm for the females and 5 x 7 cm for the males
- % coverage: 10% of the body surface of the animals.
- Type of wrap if used: restraining bandage (Laboratoires 3M Santé, 92245 Malakoff, France)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5ml/kg


Duration of exposure:
Single
Doses:
2000mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: The animals were observed frequently after application of the test substance and at least once a day for 14 days in order to determine the reversibility or irreversibility of any clinical signs.
Mortality: The animals were checked frequently for mortality and signs of morbidity just after administration of the test substance and at least twice a day during the 14-day observation period.
Body weight: The animals were weighed individually just before application of the test substance and then on days 5, 8 and 15. The body weight gain of the treated animals was compared to a reference curve of C.I.T. control animals with the same initial weight.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the observation period.
Clinical signs:
No clinical signs were observed during the study.
Between days 2 and 15, signs of necrosis of the skin without tissular lesions on the whole depth of the skin were observed on the area receiving the test substance.
Body weight:
Between days 1 and 5, a decrease in the body weight of 4 males and 1 female (No. 05) was noted without subsequent consequence. The variations
in body weight recorded within the days following treatment were probably due to the severe cutaneous reactions. The body weight gain of the other
animals was normal.
Gross pathology:
No apparent abnormalities. Signs of necrosis due to the application of the test substance were observed at the application site of all animals.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the experimental conditions, the dermal LD0 of the test substance n-HEPTYLAMINE was higher than 2000 mg/kg.
Executive summary:

The potential acute toxicity of the test substance n-HEPTYLAMINE was evaluated in rats according to the recommendations of the O.E.C.D. Guideline No. 402 (O.E.C.D., 24th February 1987) administered by dermal route and the Principles of Good Laboratory Practice (O.E.C.D., 12th May 1981) . The test substance was applied in its original form directly to the skin of 10 Sprague-Dawley rats (5 males and 5 females) at a dose level of 2000 mg/kg, taking into consideration that the specific gravity (SG) of the test substance was 0.773. After 24 hours under a semi-occlusive dressing, no residual test substance was observed at removal of the dressing. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days after the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study. No clinical signs were observed after application of the test substance. Between days 2 and 15, signs of necrosis of the skin without tissular lesions on the whole depth of the skin were observed on the area receiving the test substance. Between days 2 and 5, the body weight gain of the females slowed down and that of the males was reduced by 5 g. The body weight gain of all animals returned to normal thereafter. No deaths occurred at the dose level of 2000 mg/kg. Under our experimental conditions, the LD0 of the test substance n-HEPTYLAMINE when administered by dermal route in rats was higher than 2000 ng/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

Additional information

Justification for classification or non-classification

According to the criteria of the CLP regulation, the substance must be classified as Acute oral toxicity cat.3. No classification is warranted for the Acute dermal toxicity.