1-chloropropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guidelines.

Justification for type of information:

Please refer to the read-across justification document attached to section 13 in IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

-reliability scoring based on 2001 guideline for Test No. 423

Deviations:

yes

Remarks:

-purity of the test article and age of the animals were not reported, and relative humidity was 50 to 85%, which exceeds guideline recommendations of 30 to 70%

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC directive 84/449/EEC, September 19, 1984.

Deviations:

yes

Remarks:

-purity of the test article and age of the animals were not reported, and relative humidity was 50 to 85%, which exceeds guideline recommendations of 30 to 70%

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-chloropropane

EC Number:

200-858-8

EC Name:

2-chloropropane

Cas Number:

75-29-6

Molecular formula:

C3H7Cl

IUPAC Name:

2-chloropropane

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Crl:(WI) BR - Wistar, white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld.
- Age at study initiation: Not reported
- Weight at study initiation: 176 to 193 g (males); 150 to 165 g (females)
- Fasting period before study: 16 hours prior to administration until 3 to 4 hours after administration
- Housing: Group housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet (e.g. ad libitum): Ssniff-R Alleindiät pellets (Ssniff Spezialdiäten GmbH); ad libitum
- Water (e.g. ad libitum): drinking water (drinking bottles); ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 50 to 85
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Oleum arachidis

Details on oral exposure:

VEHICLE
-Test article was administered as a 20% dilution in Oleum arachidis.
-The pH value was 6.5.

MAXIMUM DOSE VOLUME APPLIED: Approximately 10 mL/kg bw

Doses:

Range finding study: 1000 and 2000 mg/kg body weight
Main study: 2000 mg/kg body weight

No. of animals per sex per dose:

Range finding study: 2 female animals (each tested at 2 dose levels)
Main study: 5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were conducted at regular intervals (20 min, 1, 2, 3, 6, and 24 hr, and thereafter once daily up to Day 14) during the 14-day observation period. Body weights were measured on Days 0, 7, and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Gross pathological examinations were performed on animals sacrificed at termination.

Statistics:

LD50 values were calculated according to Finney D.Y., Probit Analysis, 3rd edition, Cambridge, 1971.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths were reported following the administration of a single dose of 2,000 mg/kg bw of isopropylchloride to rats.

Mortality:

Range finding study: No deaths in the preliminary study were reported.
Main study: No animals died during the course of the main study.

Clinical signs:

No abnormal clinical signs were observed.

Body weight:

Weight gains were normal in all animals.

Gross pathology:

No test-article-dependent findings were reported following gross pathological examination on Day 14. The authors reported that the macroscopic changes observed were attributed to the sacrificing procedure or to minor variations, which often occur spontaneously in rats of this strain and age.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

CLP: Acute toxicity, Cat. 4, H302