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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-chloromethylpyridine
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:
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, salivary fluid, strong blood circulation, hairless body parts and partly piloerection. The symptoms occurred relatively quickly after the application and disappeared at the latest on the third day of the study.
Body weight:
Body weight development was normal for both sexes.
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.