Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near-guideline study, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Dioctylamine
EC Number:
214-311-6
EC Name:
Dioctylamine
Cas Number:
1120-48-5
IUPAC Name:
N-octyloctan-1-amine
Details on test material:
Liquid product di - n - octylamin supplied by Ruhrchemie Aktiengesellschaft.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tuck and Sons Limited, Battlesbridge, Essex
- Weight at study initiation:150-250 gram
- Fasting period before study: night before dosing
- Housing: 5 per group
- Diet: ad libitum
- Water : ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A range finding study was performed using one male and one female per group at: 0.06, 0.12, 0.5, 1.0 and 2.0 mL/kg.
The animals were observed for 5 days and mortality was recorded.
Doses:
0.06, 0.19, 0.62 and 2.0 mL/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were given a single oral dose of the test material at the levels given above, and were observed at 1/4, 1 and 4 hours and then once daily for fourteen days and the mortalities recorded. Evidence of overt toxicity was also noted.
One male and one female survivor from each group (where available) were subject to gross necropsy at termination of the study. Any macroscopic abnormalities were recorded.
Statistics:
no data, expect calculation of 95% confidence limits.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.484 mL/kg bw
Based on:
test mat.
95% CL:
0.309 - 0.757
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 338 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Assuming a density of 0.7 g/ml
Mortality:
total mortality after 14 days:
At 0.06 ml/kg: 0
At 0.19 ml/kg: 1
At 0.62 ml/kg: 6
At 2.0 ml/kg: 10
Clinical signs:
other: One female rat in the 0.06 ml/kg group became ataxic within 24 hours of dosing but had recovered after 48 hours. The remaining animals in this group showed no abnormal symptoms throughout the observation period. Clinical effects at the 0.19 ml/kg level co
Gross pathology:
Necropsy of one male and one female survivor from each group revealed no abnormal macroscopic lesions.
Other findings:
No data.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute oral toxicity LD50 is 338 mg/kg, resulting in a classification of Toxicity Cat IV