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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD guideline study, with acceptable restrictions (no data on test substance purity, limited documentation)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(adopted 1987)
Deviations:
yes
Remarks:
(limited documentation)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trioctylamine
EC Number:
214-242-1
EC Name:
Trioctylamine
Cas Number:
1116-76-3
Molecular formula:
C24H51N
IUPAC Name:
N,N-dioctyloctan-1-amine
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Tri-N-Octylamine
- Analytical purity: no data
- Impurities (identity and concentrations): no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, D-7950 Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: anmals of comparable weight ( ± 20% of the mean weight)
mean weight: males 191 g; females 181 g
- Fasting period before study: 16 hrs before administration of the test substance
- Housing: 5 animals per cage, in stainless steel wire mesh cages, Type DK-III
- Diet (ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Amount of vehicle (if gavage): 5 mL/kg bw
- Justification for choice of vehicle: The test substance is insoluble in water.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Recording of signs and symptoms were performed several times on the day of administration, then at least once each workday. A check for moribund and dead animals was performed twice each workday and once on holidays.
Body weights of individual animals were recorded before test start. After 7 and 13 days, group-wise documentation of body weights was performed.

- Necropsy of survivors performed: yes
Food was withdrawn about 16 hrs before sacrifice with CO2. Then, necropsy with gross-pathological examination was performed. Necropsy of all animals that died during the study, was conducted as early as possible.

- Other examinations performed: clinical signs, body weight: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
On day 7 one male rat out of five and one female rat out of five rats treated with 2000 mg/kg bw of the test substance died. The remaining animals survived until the end of the observation period (14 days after administration). 20 % mortality was observed during the present study.
Clinical signs:
Male animals:
- no abnormalities

Female animals:
- from day 5 until day 6: dyspnoea, apathy and poor general state
- from day 5 until day 7: spastic gait and piloerection
- on day 7: impaired general state
Body weight:
Male animals:
Body weights of the male rats increased within the normal range throughout the study period (249 g after 7d, 283 g after 13 d).

Female animals:
Body weights of the female rats did not increase during the first study week, but decreased slightly (179 g), then started to increase during the second week (199 g).
Gross pathology:
Deceased animals: general congestion.

Sacrificed animals: no pathologic findings noted.

Any other information on results incl. tables

Mean body weights:

 

Mean body weights [g]

After x days [d]

males

females

0

191

181

7

249

179

13

283

199

Applicant's summary and conclusion

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