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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:
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. The symptoms occurred relatively quickly after the application and disappeared at the latest on the second day of the study.
In both sexes also skin changes were observed in the application area, namely thickening and crusts in the affected skin areas.

Body weight:
Body weight development was normal for both sexes.
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.

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