Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chlorohexane
EC Number:
208-859-5
EC Name:
1-chlorohexane
Cas Number:
544-10-5
Molecular formula:
C6H13Cl
IUPAC Name:
1-chlorohexane

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males 215 g, females 148 g
- Housing: 1-5 animals per cage (Makrolon type III)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26.07.1982 To: 28.07.1982

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
paraffin oil
Details on oral exposure:
DOSE VOLUME APPLIED: 10 ml/kg
Doses:
1990, 3980, 5010, 6310, 7940, 8780 mg/kg bw
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: observation up to 6 hours after application and daily thereafter
- Frequency of weighing: before application and 1, 7 and 14 days thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 value was determined according to Litchfield and Wilcoxon (J. Pharmacol. Exp. Ther. 96, 1949, 99).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7 000 mg/kg bw
Based on:
test mat.
95% CL:
5 623 - 9 310
Mortality:
1990 mg/kg: 0/5 females, 0/5 males
3980 mg/kg: 2/5 females, 0/5 males
5010 mg/kg: 3/5 females, 0/5 males
6310 mg/kg: 2/5 females, 1/5 males
7940 mg/kg: 4/5 females, 1/5 males
8780 mg/kg: 5/5 females, 4/5 males

Deaths occured within 7-96 h after application. 
Clinical signs:
All animals were affected. 1 h p.a. piloerection, 2 h p.a. ataxia, lateral position and sedation occured, that were reversible within 48-96 h. 
Body weight:
No changes in body weight gain.
Gross pathology:
Liver congestion and blood in the small intestine was observed in several animals. No substance related macroscopic findings in surviving animals.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
In this acute oral toxicity study in the rat a combined LD50 value of 7000 mg/kg bw was found. Acute clinical signs were observed in all dose groups which were reversible within 48-96 h p.a. .