1,2,3-trichloropropane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: - followed recognized toxicology testing procedures - GLP compliant - study results copied without further assessment from the SIDS dossier

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Reference 2

Reference Type:

secondary source

Title:

SIDS INITIAL ASSESSMENT REPORT For SIAM 18 - 1,2,3-Trichloropropane

Author:

OECD

Year:

2004

Bibliographic source:

Published OECD SIDS initial assessments of HPV chemicals: http://www.oecd.org/document/63/0,3343,en_2649_34379_1897983_1_1_1_1,00.html

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FIFRA Pesticide Assessment Guidelines, Subdivision F, 81-3 (1982) and TSCA, Health Effects Test Guidelines, Acute inhalation Exposure.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-trichloropropane

EC Number:

202-486-1

EC Name:

1,2,3-trichloropropane

Cas Number:

96-18-4

Molecular formula:

C3H5Cl3

IUPAC Name:

1,2,3-trichloropropane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported in SIDS dossier study summary
- Age at study initiation: not reported in SIDS dossier study summary
- Weight at study initiation:males: 289 - 310 g; females: 167 - 176 g
- Fasting period before study: not reported in SIDS dossier study summary
- Housing: not reported in SIDS dossier study summary
- Diet (e.g. ad libitum): not reported in SIDS dossier study summary
- Water (e.g. ad libitum): not reported in SIDS dossier study summary
- Acclimation period: not reported in SIDS dossier study summary

ENVIRONMENTAL CONDITIONS
- not reported in SIDS dossier study summary

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

other: not clearly reported in SIDS dossier study summary, expected to be whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: New York University-style stainless steel chamber (300 L) with a pyramidal top and bottom.
- Exposure chamber volume: 300 L
- Method of holding animals in test chamber: not reported in SIDS dossier study summary
- Source and rate of air: Airflow rate was 63.9 L/min
- Method of conditioning air: not reported in SIDS dossier study summary
- System of generating vapor: liquid was metered to a Laskin-style nebulizer (sonic jet orifice) which generated the test atmosphere
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: 26 °C; relative humidity: 35%; oxygen level: 21%.

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: not reported in SIDS dossier study summary

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gas chromatography

Duration of exposure:

4 h

Concentrations:

4800 mg/m³

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 observations and weighing: pre exposure and at selected intervals post exposure
- Necropsy of survivors performed: yes

Statistics:

not reported in SIDS dossier study summary

Results and discussion

Preliminary study:

no

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4 800 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: limit test

Mortality:

- no mortality at the limit dose

Clinical signs:

other: - during exposure: hypoactivity, lacrimation and slow labored breathing; - post exposure: periocular wetness, clear nasal discharge, hypoactivity, labored respiration, gasping, rattling sounds in lungs, red/brown perinasal encrustation and ataxia.

Body weight:

- a slight body weight decrease was seen for the first 2 days post exposure.

Gross pathology:

- no adverse findings at necropsy

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute respiratory toxicity of 1,2,3-trichloropropane was tested in compliance with OECD TG 403 in Sprague-Dawley rats of both sexes at a limit dose of 4800 mg/m³ (exposure duration = 4 h). No fatalities occurred. Based on this result 1,2,3-trichloropropane should not be classified according to CLP.

Executive summary:

In the present study (Monsanto 1987) the acute respiratory toxicity of 1,2,3-trichloropropane was tested in compliance with OECD TG 403 in Sprague-Dawley rats of both sexes at a limit dose of 4800 mg/m³ (exposure duration = 4 h). No fatalities occurred. Based on this result 1,2,3-trichloropropane should not be classified according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

Animals were probably whole body exposed in a New York University-style stainless steel chamber (temp.: 26 °C; relative humidity: 35%; oxygen level: 21%). Test item concentrations were analysed by gas chromatography. Animals were subsequently observed for clinical signs and body weight effects and sacrificed and necropsied 14 days after the exposure.

No fatalities occured at this limit dose, while during exposure hypoactivity, lacrimation and slow labored breathing was reported. Post exposure periocular wetness, clear nasal discharge, hypoactivity, labored respiration, gasping, rattling sounds in lungs, red/brown perinasal encrustation and ataxia were seen.At necropsy nevertheless no adverse effects were reported.