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
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,2-diol
EC Number:
226-285-3
EC Name:
Pentane-1,2-diol
Cas Number:
5343-92-0
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,2-diol

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 171 g - 210 g
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: animals were caged in groups of 5 in Macrolon cages type 3
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55 % +/- 15 %
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- water

MAXIMUM DOSE VOLUME APPLIED:
- volume applied: 10 ml/kg bw

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: mortality => daily a.m. and p.m. on working days; signs and symptoms => daily;
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable , the LD50 including the 95 % confidence limit were computed by the logit method.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: Sedation (up to 5 hours after administration), dyspnoe (up to 12 days after administration), exophtalamus (up to 11 days after administration), ruffled fur (up to 8 days after administration), and a curved body position (up to 7 days after administration)
Gross pathology:
No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined for the test item: LD50 > 5000 mg/kg bw