Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test to assess acute toxicity in mice after intraperitoneal substance application
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Valeric acid
EC Number:
203-677-2
EC Name:
Valeric acid
Cas Number:
109-52-4
Molecular formula:
C5H10O2
IUPAC Name:
pentanoic acid
Details on test material:
- Name of test material (as cited in study report): Valeric acid, substance ID: 77/505
- Physical state: clear liquid
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Mean weight at study initiation: male: 30 g; female: 24 g
- Fasting period before study: no data
- Housing: groups of five
- Diet: ad libitum
- Water: Tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
olive oil
Doses:
21.5, 100, 200, 464, 700, 2150 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females (200 and 700 mg/kg bw)
2 males and 2 females all other dosing groups
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
200 - 464 mg/kg bw
Mortality:
21.5 mg/kg dosing group: no death occurred
100 mg/kg dosing group: no death occurred
200 mg/kg dosing group: no death occurred
464 mg/kg dosing group: all animals died
700 mg/kg dosing group: all animals died within 7 days
2150 mg/kg dosing group: all animals died within 7 days
Clinical signs:
dyspnoea, apathy, abdominal position, staggering, spastic gait, exsiccosis, bad general condition
Body weight:
normal body weight gain
Gross pathology:
Organs without findings

Applicant's summary and conclusion