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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study based on national and scientific standards, basic data given, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Synprolam 35 (trade name)
- Substance type: organic
- Physical state: liquid, clear
- Melting point: 12.5 °C
- Boiling point: 263 °C
- Density: 0.806 g/mL (20 °C)
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data in the Report
data adopted from the precursor aldehyde mixture (SYNPRAL 135):
- n-tridecylamine 33 % (m/m)
- isotridecylamine 33 % (m/m)
- n-pentyldecylamine 14 % (m/m)
- isopentylamine 14 % (m/m)
- other components 6 % (m/m)

[Reference: ICI 1975/1976: Synthetic fatty amines - Synpral 135 (Synprolaldehyde; C13/C15 alkyl aldehyde). MSDS]

Test animals

Species:
rat
Strain:
other: CFY strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100 - 120 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg bw

Doses:
0, 1.0, 1.6, 2.5, and 4 mL/kg bw (~800, 1300, 2000, and 3200 mg/kg bw)
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Calculation of the LD50 and 95% C.I. based on Litchfield and Wilcoxon, J. Pharmac. Exp. Ther., 96, 99-113 (1949)

Results and discussion

Preliminary study:
Preliminary range finding study was conducted on 2 animals per dose group (one male and one female) at 0, 1.0, and 4.0 mL/kg bw. Only in the highest dose group mortality was observed in both rats < 21 hourse after dosing.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1.6 mL/kg bw
Based on:
test mat.
95% CL:
>= 1.1 - <= 2.2
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 300 mg/kg bw
Based on:
test mat.
95% CL:
ca. 880 - ca. 1 760
Remarks on result:
other: Estimates using a density of 0.8 g/mL
Mortality:
Death occurred from within 21 to 70 h of treatment. Autopsy revelaed darkenning of the liver and kidneys and injection of mesenteric blood vessels.
Clinical signs:
Shortly after dosing: lethargy, piloeerection, diuresis, diarrhea, increased salivation, and fine body tremor; later on: additionally ataxia at 1.6 and 2.5 mL/kg bw and lacrimation at 2.5 mg/kg bw.
Body weight:
Slightly depressed body-weight gain in survivors during the first week.
Gross pathology:
Darkening of livers and kidney and injection of mesenteric blood vessels.

Any other information on results incl. tables

Summary of Mortality Data (from Report, Tab. 2)

Dose [mL/kg bw]

Male rats

Female rats

Total

Absolute number of deaths

0

0/3

0/3

0/6

1.0

0/3

1/3

1/6

1.6

2/3

1/3

3/6

2.5

3/3

3/3

6/6

4.0

3/3

3/3

6/6

Time of death after dosing:

Men:

1.6 mg/kg: < 70 h

2.5 mg/kg; < 46 h

4.0 mg/kw: < 22 h

Women:

1.0 mg/kg: < 46 h

1.6 mg/kg: < 22 h

2.5 mg/kg; < 51 h

4.0 mg/kw: < 22 h

Evaluation of Bodyweight after dosing in g

 Sex Dosage in mL/kg  Bodyweight at Dosing in g    Bodyweight after 1 week in g    Bodyweight after 2 weeks in g 

    male

 0

107

185 

231 

 1.0

113 

153 

209 

 1.6

112 

152 

210 

 2.5

111

Died 

 4.0

111 

Died 

   femal

 0

106 

162 

185 

 1.0

111 

139 

174 

 1.6

112 

136 

167 

 2.5

115 

Died 

 4.0

110 

Died 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the experimental data an oral LD50 of 1.6 mL/kg bw was calculated for males and females resulting in an LD50 of around 1300 mg/kg bw.
Executive summary:

The acute toxicity of the test item was investigated (n= 3 males and females per dose group). Rats received single undiluted oral doses of the test item by oral intubation and were observed for 14 days thereafter. Clinical signs like lethargy, piloeerection, diuresis, diarrhea, increased salivation, and fine body tremor were observed shortly after dosing. These signs were later accompanied by ataxia at 1.6 and 2.5 mL/kg bw and by increased lacrimation at 2.5 mg/kg bw.

Death occured from within 21 to 70 hours of treatment. Autopsy revealed darkening of the liver and kidneys and injection of mesenteric blood vessels.

Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within five days of treatment. Slightly depressed bodyweight gains were observed during the first week of observation, but returned to normal during the second week, compared with controls.

Terminal autopsy findings were normal.

Based on the experimental data an oral LD50 of 1.6 mL/kg bw was calculated for males and females resulting in an LD50 of around 1300 mg/kg bw.