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Toxicological information

Acute Toxicity: oral

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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.

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
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
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

Constituent 1
Reference substance name:
2-Chlorbutan
IUPAC Name:
2-Chlorbutan
Constituent 2
Reference substance name:
sec-Butylchloride
IUPAC Name:
sec-Butylchloride
Constituent 3
Chemical structure
Reference substance name:
2-chlorobutane
EC Number:
201-151-7
EC Name:
2-chlorobutane
Cas Number:
78-86-4
Molecular formula:
C4H9Cl
IUPAC Name:
2-chlorobutane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): sec-butylchloride; 2-chlorbutan
- Physical state: liquid
- Analytical purity: Not reported
- Lot/batch No.: Not specified by sponsor
- Expiration date of the lot/batch: Provided by the sponsor; however, not reported in the study report
- Stability under test conditions: Not specified by sponsor
- Storage condition of test material: Max. 5°C, in the dark

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: 160 to 174 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 6.6.

MAXIMUM DOSE VOLUME APPLIED: Approximately 10 mL/kg bw
Doses:
Range finding study: 1000 and 2000 mg/kg body weight, conducted on four female rats
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
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 sec-butylchloride 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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (oral, rat) in this valid guideline study was determined to be > 2000 mg/kg bw.
Executive summary:

No mortality was observed in this study when dosed 2000 mg/kg bw in rats. Consequently, as a result the substance 2 -chlorobutane is not classifiable according to CLP (Regulation (EC) No 1272/2008, DSD (Directive 67/548/EEC) nor GHS for acute oral toxicity.

As no study related effects were observed during the study regards weight gain or at gross pathological examination, no indication for Target Organ Syste Toxicity at Single Exposure classification is given (STOT SE).