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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
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD Guideline 401 in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Genamin 18R 100 D

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:
- male: ca. 7 weeks
- female: ca. 8 weeks
- Weight at study initiation:
- male:
- mean: 195 g
- min: 178 g
- max: 208 g
- sd: +- 11g
- n = 5
- female:
- mean: 189 g
- min: 186 g
- max: 192 g
- sd: +- 3g
- n = 5
- Housing: fully airconditioned rooms, makrolon cages on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: min. 5 days
- no feeding 16 hrs prior and 3-4 hours past application of the test-substance

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
- Concentration in vehicle: 20% (w/v)
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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
2000 mg/kg: 1 / 5
Clinical signs:
disequilibrium, dyspnoe, convulsions
Body weight:
An impairment (interference) of the body-weight development was not observed.
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings

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 Octadecylamine (LD50) was greater 2000 mg per kg body weight in both male and female rats. Based on the result of this study Octadecylamine is not subject for labelling and classification requirements according to regulatory requirements
Executive summary:

The study of the acute oral toxicity of Genamin 18 R 100 D (octadecylamine) to 5 male and 5 female Wistar rats resulted in a median lethal dose (LD50) of greater 2000 mg/kg body weight. After the application of 2000 mg/kg body weight one male animal deceased on day four after application. Animals showed beside unspecific signs of poisoning impairment of breathing and in motion. For one male animal a swollen stomach was observed additionally. An impairment (interference) of the body-weight development was not observed. Macroscopic findings of toxicological significance were not observed during gross pathology at the end of the observation period.