Reaction mass of 1,3-dichloropropene and 2-chloropropane and 2-chloropropene and 3-chloropropene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to O.E.C.D. Testing Guideline 401 without GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropene

EC Number:

203-457-6

EC Name:

3-chloropropene

Cas Number:

107-05-1

Molecular formula:

C3H5Cl

IUPAC Name:

3-chloroprop-1-ene

Details on test material:

As per the IUCLID5 Sections 1.1. - 1.4. for 3-chloropropene.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley rats were acquired from Spartan Research Animals, Inc., Haslett, Michigan and the CDF (Fischer 344-derived) rats were from Charles River Breeding Laboratories, Inc., Portage, Michigan. The age of the animals at study initiation was 7-8 wks and the average body weights at study initiation were: Sprague Dawley males; 308 gm, Sprague Dawley females; 192 gm, CDF males: 136 gm, CDF females 88 gm. The Fasting period before dosing was 16-18 hours. Animals were housed 2 or 3/cage. Animals were feed a diet ad libitumof commercial laboratory chow (Ralston Purina Company, St. Louis, Missouri). Water was offered ad libitum. The mean temperature was 22.8 °C with mean relative humidity of 45% and the Photoperiod (hrs dark / hrs light) was 12/12.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Dosing was by oral gavage based on test substance voume and animal body weight.

Doses:

The CD rats and male CDF rats were treated with four dose levels of the testr substance over a dose range of 200 - 1580 g/Kg. The female CFD rats were treated with six dose levels from 63 - 1580 mg/Kg.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The observation period following administration of the test substance was 14 days. Animals were observed daily for clinical signs and weighed immediately prior to treatment, and weekly thereafter. Necropsy was performed on surviving animals at termination.

Statistics:

The acute oral median lethal dose, 95% confidence interval, and approximate slope of the dose-response curve for both strainsof rats was calculated by the moving average method of Thompson and Weil (Thompson, W. R. and C. S. Weil, Biometrics, Vol. 8, No. 1, March, 1952, pp. 51-54. As implemented in a computer program (Stephan, 1978).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

275 mg/kg bw

Based on:

test mat.

95% CL:

180 - 526

Mortality:

All animals died at the high dose level of 1580 mg/Kg and only one animal (1/20) survived at 795 mg/Kg. Approximately 50% of theanimals died at 398 mgKg.

Clinical signs:

other: Clinical signs comprised slight to extreme lethargy, diarrhea, piloerection and convulsions observed in a dose-dependent manner.

Gross pathology:

The following lesions were found that appeared to be test substance related: Lungs; multiple pinpoint gray foci scattered throughout all lobes,
Stomach; thickening and roughening of nonglandular squamous epithelium, focal thickening of nonglandular stomach wall, erosion of nonglandular epithelium, firm, nodular-like foci throughout epithelial surface, perforated ulcer and fibrous adhesions between stomach and liver, spleen, or diaphragm.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

Migrated information: based on findings from the female CDF rats.

Conclusions:

The test substance 3-chloropropene with estimated oral LD50 of 275 - 400 mg/Kg is Harmful if sallowed. These findings are believed to be representative of AC Light Ends.

Executive summary:

The structurl analog, 3 -chloropropene was assessed for its acute oral toxicity in an O.E.C.D. Testing Guideline 401 study in Sprague-Dawley and Fisher-344 derived CDF rats. The femal CDF rats appeared to be the most sensitive to treatment with an estimated LD50 of 275 mg/Kg. The test substance 3-chloropropene with estimated oral LD50 of 275 - 400 mg/Kg is Harmful if sallowed. These findings are believed to be representative of AC Light Ends.