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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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