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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan to Feb 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
454-800-3
EC Name:
-
Cas Number:
70258-18-3
Molecular formula:
C6H5Cl2N
IUPAC Name:
2-chloro-5-(chloromethyl)pyridine
Test material form:
solid
Specific details on test material used for the study:
- Stability under test conditions: The formulation was prepared for immediate use and administration was carried out within 1 hour.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Germany
- Age at study initiation: 7-8 weeks (males), 10-11 weeks (females)
- Weight at study initiation: 162-180 g (males), 173-184 g (females)
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
Males: 100, 250, 500, 750, 2000 mg/kg bw
Females: 100, 250, 500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Administration volume: 5 mL/kg
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 1, 4, 8 and 14
- Necropsy of survivors performed: yes
Statistics:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 250 - < 500 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 100 - < 250 mg/kg bw
Based on:
test mat.
Mortality:
Males: After treatment with 100 or 250 mg/kg bw no animals died (0/5). After treatment with 500, 750 or 2000 mg/kg bw all animals died (5/5) within 1 day.
Females: After treatment with 100 mg/kg bw no animals died (0/5). After treatment with 250 or 500 mg/kg bw 4/5 or 5/5 animals died within 5 hours.
Clinical signs:
other: At 250 mg/kg bw and above male and female animals showed the following clinical signs: Apathy, labored breathing, staggering gait, reduced motility, partly abdominal or lateral position, partially low reflexes, lacrimation, closed palpebral fissures, sali
Gross pathology:
In the animals died after administration, the following gross pathological findings were recorded: Lungs blown, partly spotted; spleen pale; liver dark; stomach partly with clear or red fluid; partly in the glandular stomach ulcus-like foci, partly reddened mucous membrane or like corroded looking mucous membranes; intestinal tract filled with clear liquid.

No findings were recorded for the animals killed at the end of the follow-up period.
Other findings:
none specified

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Executive summary:

According to OECD TG 401 the acute oral toxicity (LD50) in rats is in the range of 250 - 500 mg/kg bw for males and in the range of 100 - 250 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after single oral administration to rats.