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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 15, 1989 to February 15, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
other: EEC Guideline 84/449/EEC
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritol
EC Number:
204-104-9
EC Name:
Pentaerythritol
Cas Number:
115-77-5
Molecular formula:
C5H12O4
IUPAC Name:
2,2-bis(hydroxymethyl)propane-1,3-diol
Constituent 2
Reference substance name:
2,2,-Bis-(hydroxymethyl)-1,3-propandiol
IUPAC Name:
2,2,-Bis-(hydroxymethyl)-1,3-propandiol
Details on test material:
- Name of test material (as cited in study report): 2,2,-Bis-(hydroxymethyl)-1,3-propandiol (pentaerythritol)
- Substance type: white crystals
- Physical state: solid
- Analytical purity: 99%, confirmed by gas chromatography
- Lot/batch No.: 885/C
- Stability under test conditions: yes, confirmed by the sponsor
- Storage condition of test material: closed container at room temperature
- Other: ph 4-5 (60 g/L H2O, 20°C)
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,2,-Bis-(hydroxymethyl)-1,3-propandiol (pentaerythritol)
- Substance type: white crystals
- Physical state: solid
- Analytical purity: 99%, confirmed by gas chromatography
- Lot/batch No.: 885/C
- Stability under test conditions: yes, confirmed by the sponsor
- Storage condition of test material: closed container at room temperature
- Other: ph 4-5 (60 g/L H2O, 20°C)

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPFCpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
The animals were male and female Bor: WISW (SPFCpb) rats, obtained from Winkelmann Versuchstierzucht GmbH & Co. Males were 11 weeks old at the start of treatment with a body weight range of 219-225 g. Females were 12 weeks old at the start of treatment with a body weight range of 159-179 g.
They were housed individually in Macrolon Cages (Type II), with animal bedding chips. They were fed a standard diet ad libitum (ssniff R, ssniff Spezialfutter GmbH), and tap water was provided ad libitum (Stadtwerke Bielefeld Municipal Works).
The room temperature was maintained at 20.0-22.5°C, and relative humidity was 40-60%. Artificial lighting was provided for 12 hours per day.
Animals were randomised to treatment groups on arrival using a computerised random figure generator. The rats were individually identified colour codes and ear notches. They rats were acclimatised for at least 5 days.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous tylose (1%)
Details on oral exposure:
The rats were fasted for approximately 16 hours prior to administration. The test substance was administered as a single oral dose by gavage, in aqueous tylose (1%). The test substance was suspended in the vehicle immediately prior to dosing using an ultraturrax homogeniser. The administration volume was set to 21.5 ml/kg. The content of the suspension was 237 mg/ml.
Doses:
5110 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The rats were observed continuously for the first 4-6 hours after administration, then once daily thereafter for 14 days. Mortality was checked twice daily (am and pm) on weekdays, and once daily on weekends and national holidays. The body weights were recorded at the beginning of the study, and 7 and 14 days after administration.
At the end of the observation period, all surviving animals were sacrificed for gross necropsy (animals that died during the observation period were also necropsied). Macroscopical examination included external appearance, body orifices, body cavities and their contents.
Statistics:
Statistical analyses were not required.

Results and discussion

Preliminary study:
No preliminary study was reported.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No mortality occurred during the study.
Clinical signs:
The only sign of toxicity was diarrhoea, recorded in 3 rats (2 males and 1 female) 7 hours after dosing. All other rats appeared normal.
Body weight:
There was no effect of treatment on bodyweight; all rats gained weight throughout the observation period.
Gross pathology:
No abnormal findings were detected at gross necropsy.
Other findings:
No other findings were reported.

Any other information on results incl. tables

The acute oral LD50 of pentaerythritol in rats is > 5110 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Pentaerythritol is of low acute oral toxicity. The acute oral LD50 of pentaerythritol in rats was found to be >5110 mg/kg bw, under the conditions of this study.
Executive summary:

Pentaerythritol was studied for acute toxicity after single oral administration in rats. The test substance was suspended in aqueous tylose (1%) and administered to a group of three rats. The single dose level was 5110 mg/kg bw, the administration volume was 21.5 ml/kg bw; the content of the suspension was 237 mg/ml. No deaths occurred. The only sign of toxicity was diarrhoea, recorded in all rats at 7 hours after gavage administration. At necropsy, no abnormal findings were found. The acute oral LD50 in the rat was therefore found to be >5110 mg/kg bw under the conditions of this study.