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EC number: 204-690-6 | CAS number: 124-22-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-01-20 to 1988-02-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD Guideline 401 and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dodecylamine
- EC Number:
- 204-690-6
- EC Name:
- Dodecylamine
- Cas Number:
- 124-22-1
- Molecular formula:
- C12H27N
- IUPAC Name:
- dodecan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Genamin 12 R 100 D
-
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
- male ca. 6 weeks
- female ca. 7 weeks
- Weight at study initiation:
- male mean = 186 g; min = 184 g, max = 190 g; sd = +-2g
- female mean = 182 g; min = 178 g, max = 186 g; sd = +-3g
- Randomized
- Fasting period before study: 16 h before application and 3-4 hours after application of the test substance
- Housing: fully air-conditioned in makrolon cages (type 4) on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum
- Acclimation period: min 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 50 +- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- - Concentration in vehicle: 20%
- Doses:
- 2000 mg/kg body weight
- 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 observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortalities
- Clinical signs:
- other: decreased spontaneous activity, coat bristling, squatting posture, stilted gait, irregular respiration
- Gross pathology:
- Dissection of rats killed at the end of the observation period revealed no macroscopic findings execpt in one case (male rat). The macroscopic finding of that animal revealed connation (intergrowth) between the stomach with liver, spleen, pancreas and abdominal wall most probably caused by the corrosive properties of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The median lethal dose of Dodecylamine (LD50) was greater 2000 mg per kg body weight. Based on the result of this study Dodecylamine is not subject for labelling and classification requirements according to regulatory requirements
- Executive summary:
In a GLP-compliant study according to OECD TG 401, the test material Genamin 12 R 100 D was orally applied to 5 male and 5 female Wistar rats using sesame oil as a vehicle at the limit dose of 2000 mg/kg body weight. After treatment no mortalities occurred during the observation period of 14 days. The LD50 was established at > 2000 mg/kg for both male and female animals. Clinical signs included squatting posture, stilted gait, irregular breathing, and reduced spontaneous activity. Symptoms started between 10-60 minutes after onset of treatment and were present until day 6 (female animals) or day 9 (male animals). Gross pathology revealed no findings except in one male animal. This animal showed partly connation of stomach epithelia with lobes of liver, spleen, pancreas and abdominal wall which was most probably caused by the corrosive properties of the test material..
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