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Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity, OECD TG 401: LD50 > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 14, 1990 - November 28, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability 2 is assigned because the study is conducted according to OECD TG 401, without deviations that influence the quality of the results but predating GLP requirements
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Fü-Albino outbred stock Ibm:RORO (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Biological Research Laboratories (BRL), CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: No data
- Weight at study initiation: males: 116.0 - 128.0 g; females: 116.0 - 121.9 g
- Fasting period before study: overnight before treatment till 4 hours after treatment
- Housing: group housing 3 animals per cage in macrolon cages type III
- Diet: free access to KLIBA 25-343 (batch 76/90), complete rodent maintenance diet
- Water: free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15 - 20 cycles
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250, 320 and 400 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: from a pilot study with the substance it was concluded that the LD50 could be near or above 2000 mg/kg.
Doses:
0, 1250, 1600 and 2000 mg/kg
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: The animals were observed 30 minutes, 1, 2 and 4 hours after application and thereafter daily
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by CO2 asphyxia, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 7th and 14th day of the observation period.
Statistics:
Not performed.
Preliminary study:
From a pilot study with the substance it was concluded that the LD50 could be near or above 2000 mg/kg.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
other: At the dose level of 1250 mg/kg, the males showed moderate to trace sedation during the first 2 hours after treatment, whereas the females remained without symptoms. In general, the observed symptoms were mild and dissappeared completely within 4 hours af
Gross pathology:
No signs of gross pathological changes were found necropsy, exept in one male in the 2000 mg/kg dose group, where the stomach was partially grown together with rate and liver tissue.

The effect seen in the stomach of the one male may be indicative for irritation of the test substance.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with male and female rats, performed according to OECD 401 test guidelines, an LD50 >2000 mg/kg bw was determined.
Executive summary:

Sec Butyl Quinoline was tested in an acute oral toxicity study with male and female rats, performed according to the OECD 401 guideline. At the dose level of 1250 mg/kg, the males showed moderate to trace sedation during the first 2 hours after treatment, whereas the females remained without symptoms. In general, the observed symptoms were mild and dissappeared completely within 4 hours after treatment, exept in one male and one female in the 1600 mg/kg dose group, which still showed symptoms like gasping and/or sedation 24 hours after tretament. No signs of gross pathological changes were found necropsy, exept in one male in the 2000 mg/kg dose group, where the stomach was partially grown together with rate and liver tissue, which may indicate some irritation of the substance. The LD50 was established to be >2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The one acute oral toxicity study available is of sufficient quality for the present dossier.

Additional information

Sec Butyl Quinoline was tested in an acute oral toxicity study with male and female rats, performed according to the OECD 401 guideline. At the dose level of 1250 mg/kg, the males showed moderate to trace sedation during the first 2 hours after treatment, whereas the females remained without symptoms. In general, the observed symptoms were mild and dissappeared completely within 4 hours after treatment, exept in one male and one female in the 1600 mg/kg dose group, which still showed symptoms like gasping and/or sedation 24 hours after tretament. No signs of gross pathological changes were found necropsy, exept in one male in the 2000 mg/kg dose group, where the stomach was partially grown together with rate and liver tissue, which may indicate some irritation of the substance. The LD50 was established to be >2000 mg/kg bodyweight.


Justification for selection of acute toxicity – oral endpoint
The result of the study is sufficiently reliable and suffiicently adequate for covering the endpoint.

Justification for classification or non-classification

Sec Butyl Quinoline does not have to be classified and labelled for acute oral toxicity in accordance with Regulation (EC) No. 1272/2008 and Directive 67/548/EEC.