Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
5-chlorovaleryl chloride
EC Number:
216-403-1
EC Name:
5-chlorovaleryl chloride
Cas Number:
1575-61-7
Molecular formula:
C5H8Cl2O
IUPAC Name:
5-chlorovaleryl chloride
Details on test material:
- Name of test material (as cited in study report): 5-chloropentanoyl chloride
- Physical state: liquid, achromatic
- Storage: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: Males: 168 - 187 g; Females: 173 - 181 g
- Fasting period before study: at least 16 hours, but water remained available
- Housing: single housing, in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG); no bedding in cages, sawdust in the waste trays.
- Diet: ad libitum, Kliba-labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland
- Water: ad libitum, tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
DAB 10
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4, 10 and 40 g/100 mL
- Administration volume: 5 mL/kg
- Justification for choice of vehicle: test substance is sensitive to hydrolysis

CLASS METHOD
- Rationale for the selection of the starting dose: A starting dose of 200 mg/kg bw was chosen based on the physical and chemical characteristics of the test substance and the composition.
Doses:
Group 1: 200 mg/kg bw
Group 2: 500 mg/kg bw
Group 3: 2000 mg/kg bw
No. of animals per sex per dose:
Group 1: 3 males & 3 females
Group 2: 3 males & 3 females
Group 3: 3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days for group 1 and 2, 1 hour for group 3
- Frequency of observations and weighing: Recordings of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
- No mortality was observed in animals exposed to 200 or 500 mg/kg bw.
- All animals exposed to 2000 mg/kg died.
Clinical signs:
- No clinical signs were observed in female animals exposed to 200 mg/kg bw.
- An impaired general state, dypnoea, staggering and piloerection were observed in all female animals exposed to 500 mg/kg bw, between 0 and 5 hours after exposure.
- A poor general state, dypnoea, apathy, staggering and piloerection were observed in all male animals exposed to 200 mg/kg bw, between 1 and 5 hours after exposure.
- An impaired general state, dypsnoea and piloerection were observed in all male animals exposed to 500 mg/kg bw, between 1 and 5 hours after exposure. In 1 male animal exposed to 500 mg/kg bw staggering was also observed, between 1 and 2 hours after exposure.
- A poor general state, dyspnoea and apathy were observed in all male animals exposed to 2000 mg/kg bw. Twitching was observed in 2 male animals, and lying in an abdominal position, staggering and rolling convulsion were observed in 1 male animal exposed to 2000 mg/kg bw. All of these effects were observed directly after exposure.
Body weight:
Mean body weight start study
- 200 mg/kg bw: Male 173 g; Female 174 g
- 500 mg/kg bw: Male 186 g; Female 180 g
- 2000 mg/kg bw: Male: 171 g

Mean body weight after 13 days
- 200 mg/kg bw: Male 254 g; Female 214 g
- 500 mg/kg bw: Male 279 g; Female 218 g
Gross pathology:
- Animals that died: A bad postmortal state was observed.
- Sacrificed animals: no pathologic findings were noted.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information