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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
-reliability scoring based on 1987 guideline
Deviations:
yes
Remarks:
purity and physico-chemical properties of test substance, sex and strain of animals, temperature, humidity, light cycle, and individual clinical signs were not reported; less than 3 dose levels tested; and less than 5 animals/sex/dose group tested
GLP compliance:
no
Remarks:
Study pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloropyridine
EC Number:
203-646-3
EC Name:
2-chloropyridine
Cas Number:
109-09-1
Molecular formula:
C5H4ClN
IUPAC Name:
2-chloropyridine
Details on test material:
- Name of test material (as cited in study report): Olin 757 (2-Chloropyridine; PD-646)
- Physical state: Liquid (clear light yellow)
- Analytical purity: Not reported. The author reported that the test compound was considered to be free of impurities.
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 2040 to 2828 g
- Fasting period before study: Not reported
- Housing: Rabbits were confined in specially constructed stock designed to hold the animal immobile (in a highly ventilated room). Twenty-four hours after application of the test compound, the animals were transferred to individual metal cages for the duration of the observation period.
- Diet (e.g. ad libitum): food was provided ad libitum
- Water (e.g. ad libitum): water was provided ad libitum
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: Not reported
- Type of wrap if used: Not reported

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Area of application was bathed with warm water.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported, but can be calculated for each rabbit based on initial body weight and on the density of the test substance (1.265 mg/mL)
- Concentration (if solution): Not applicable
Duration of exposure:
24 hours
Doses:
200 or 2000 mg/kg body weight
No. of animals per sex per dose:
3 animals/sex/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently during the first 4 hours after application, at 24 hours, and once daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: LD50 was not identified
Effect level:
other: no LD50 identified
Remarks on result:
other: 5 out of 6 rabbits died in the 200 mg/kg body weight dose group and all rabbits died in the 2000 mg/kg body weight dose group
Mortality:
200 mg/kg body weight dose group:
2 animals died within 18 hours; 3 animals died within 48 hours; and one animal with intact skin survived at the end of the study period

2000 mg/kg body weight dose group:
All animals tested died within 18 hours.
Clinical signs:
other: Death was preceded by cyanosis, bradypnea and dyspnea, lacrimation, hypothermia, and hypotonia of the skeletal musculature for both dose groups. The one animal that survived at the end of the study period (administered 200 mg/kg body weight) demonstrated
Gross pathology:
Rabbits at the 200 mg/kg body weight dosage level exhibited excessive mucous in the stomach, as well as lungs which failed to collapse, and which were congested and hemorrhagic. Fluid was found in the thoracic cavity and a strong odor of compound was present in the thoracic cavity. One animal displayed a hemorrhagic cecum. The surviving rabbits in this group exhibited no gross lesions.
At the 2000 mg/kg body weight dosage level all rabbits exhibited excessive mucous in the stomach, lungs which failed to collapse and which were congested and hemorrhagic. Foam was present in the trachea and major bronchi. A strong compound odor was present in the thoracic cavity of all rabbits at this dosage level.
Other findings:
Dermal irritation:
All 3 rabbits which survived the 200 mg/kg body weight dose level for 48 hours exhibited mild erythema and edema at the 24-hour evaluation period. The one rabbit surviving this dose level for the entire 14-day observation period exhibited mild erythema for the entire period. The authors concluded that based on the dermal irritation observed in the one animal which survived the full 14-day observation period, 2-chloropyridine does not produce severe irritation to the skin when applied in the manner described.

Applicant's summary and conclusion