Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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 guidelineopen allclose all
Qualifier:
according to
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%
Qualifier:
according to
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. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl:(WI) BR - Wistar, white
Sex:
male/female
Details on test animals 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