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Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal 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

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: 9 weeks (males), 14-16 weeks (females)
- Weight at study initiation: 208-237 g (males), 207-228 g (females)
- Housing: 1 animal 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

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: max. 5 cm x 6 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin areas were cleaned with soap and water
- Time after start of exposure: ca. 24 hours after start of exposure
Duration of exposure:
24 hours
Doses:
Males: 100, 250, 750, 2000 mg/kg bw
Females: 100, 500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- 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 - < 750 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 100 - < 500 mg/kg bw
Based on:
test mat.
Mortality:
Males: After treatment with 100 or 250 mg/kg bw 0/5 or 1/5 animals died within 2 days. After treatment with 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 500 mg/kg bw all animals died (5/5) within 1 day.
Clinical signs:
other: At 250 mg/kg bw and above male and female animals showed the following clinical signs: Apathy, labored breathing and reddened eyelids. In addition, in males after 2000 mg/kg bw reflex reduction and strong blood circulation of hairless body parts were seen
Gross pathology:
In the animals died after application, the following gross pathological findings were recorded: Liver dark; spleen pale; lungs blown, partly spotted; glandular stomach reddened, partly ulcus-like foci; occasionally stomach filled with liquid mash.

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 402 the acute dermal toxicity (LD50) in rats is in the range of 250 - 750 mg/kg bw for males and in the range of 100 - 500 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after acute dermal administration to rats.