Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an O.E.C.D. Testing guideline with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
The animals were acquired from Charles River, U.K. They were housed in groups of three rats in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding. The animal bodyweights were in the range 198 to 226 g and they were approximately eight to twelve weeks of age prior to dosing. Their acclimation period was six days.

The animal room temperature and relative humidity controls were set to maintain the range of 19 to 23 degrees C and 40 to 70% respectively. Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours. The animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet), except for overnight prior to and approximately four hours after dosing. Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The appropriate dose volume of the test substance was administered to each rat by oral gavage using a plastic syringe and plastic catheter. Formulations were stirred before and throughout the dosing procedure.
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
3 females only
Control animals:
other:
Details on study design:
The test substance, Crude 1,3-dichloropropene was formulated at a concentration of 30 and 200 mg/mL in corn oil and administered at a volume of 10 mL/kg bodyweight. The test substance formulations were prepared on the day of dosing.

Following oral gavage dosing the animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, surviving animals were observed once in the morning and again at the end of the experimental day. The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation. The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15 or at death. Individual weekly bodyweight changes and group mean bodyweights were calculated.

All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.
Statistics:
No data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female dosed at 2000 mg/kg died on Day 1 and two on Day 2.
Clinical signs:
Clinical signs prior to death comprised underactivity, partially closed eyelids, piloerection, hunched posture, post salivation staining, irregular breathing, lachrymation, closed eyelids, and reduced body tone in all animals, loose faeces in two animals and gasping, unsteady gait and flat posture in one animal. These signs were seen from approximately 30 minutes after dosing. Recovery of surviving animals, as judged by external appearance and behaviour, was complete by Day 4.
Body weight:
All surviving animals were considered to have achieved satisfactory bodyweight gains between Days 1-8, however low bodyweight gains were recorded for all animals dosed at 300 mg/kg between Days 8-15.
Gross pathology:
Macroscopic examination of the animals that died on study revealed congestion (characterised by darkened tissues/organs) of the subcutaneous tissue in all animals and the heart and lungs in two animals, pallor of the liver and spleen, lungs and kidneys small spleen and caecum yellow fluid contents of the stomach, duodenum and small intestines in all animals and large intestines in two animals and pale areas on the liver. Surviving animals at study termination did not exhibit any gross pathology findings.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Crude 1,3-Dichloropropene was found to have an acute oral LD50 in the female rat of between 300 and 2000 mg/kg bodyweight. Therefore, Crude 1,3-Dichloropropene is included in Toxicity Category 4, according to the Globally Harmonised System (GHS), (UNITED NATIONS, 2005).
Executive summary:

Crude 1,3 -dichloropropene was assessed for acute oral toxicity in the rat by O.E.C.D. Testing Guideline 423, "Acute Oral toxicity - Acute Toxic Class Method" with GLP compliance. All three female rats died at the high dose level of 2000 mg/kg of body weight. Crude 1,3-Dichloropropene was found to have an acute oral LD50 in the female rat of between 300 and 2000 mg/kg bodyweight. Therefore, Crude 1,3-Dichloropropene is included in Toxicity Category 4, according to the Globally Harmonised System (GHS), (UNITED NATIONS, 2005).