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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Internal BASF-method was used, which was in large part equivalent to methods described in OECD guideline 401
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,5-diol
EC Number:
203-854-4
EC Name:
Pentane-1,5-diol
Cas Number:
111-29-5
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,5-diol
Details on test material:
- Name of test material (as cited in study report): Pentandiol-1,5 techn.
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean weight 205 g (male), 165 g (female)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%, 46.4%, 68.1%, 100%
- Amount of vehicle (if gavage): 6.8, 10.0 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10.0 ml/kg bw
Doses:
1000, 4640, 6810, 10000
No. of animals per sex per dose:
1000 - 4640 mg/kg bw: 2 female
6810 - 10000 mg/kg bw: 5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to study and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 10 000 mg/kg bw
Mortality:
10000 mg/kg bw:
- male: 3/5 deaths within 24 h
- female: 0/5 deaths

6810 mg/kg bw:
- male: 0/5 deaths
- female: 1/5 deaths within 24 h

1000 - 4640 mg/kg bw: no deaths
Clinical signs:
- reduced state and deaths observed on first 24 h
- staggering, paresis, spastic gait, salivation, exsiccosis
Body weight:
- in the beginning reduced gain of weight
Gross pathology:
Heart: acute dilatation, congestive hyperemia
Stomach: : bloody olcerations
Gut: diarrhotic content, hematonic content
Bladder: abnormal content

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU