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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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 403 (Acute Inhalation Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
traditional 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

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: ca. 2-3 months
- Weight at study initiation: approx. 170-210 g
- 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:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: polyethylene glyocol / ethanol 50/50 (v/v)
Mass median aerodynamic diameter (MMAD):
>= 1.32 - <= 1.51 µm
Geometric standard deviation (GSD):
>= 1.81 - <= 1.98
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
analytical concentrations: 131.8, 896.3, 1404.1 mg/m3 air
No. of animals per sex per dose:
control groups: 10
dose groups: 5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: clinical signs were examined several times on the day of exposure and at least once daily therafter; body weights were measured before exposure, on days 3 and 7, and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: reflex measurements were made on the first post-exposure day.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 404 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: maximum technically attainable concentration
Mortality:
No animals died during exposure and post-observation period up to the maximal technical attainable concentration of 1404 mg/m3.
Clinical signs:
other: At 132 mg/m3 and above all rats showed slightly reddened noses on the exposure day. There were no signs of a concentration-dependent pronounced amplification of this effect.
Body weight:
Body weight development was normal for both sexes.
Gross pathology:
No gross pathological findings were observed.
Other findings:
The reflex measurements carried out on the first post-exposure day did not reveal any treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
other: no acute hazard potential
Executive summary:

According to OECD TG 403 the acute inhalation toxicity (LC50) is > 1404 mg/m3 air ( maximum technically attainable concentration) for male and female rats. Thus, the test substance revealed no acute hazard potential under the described experimental conditions after a single 4 -hour inhalation exposure to rats.