Registration Dossier

Administrative data

Description of key information

Pentaerythritol is demonstrated to be of very low acute toxicity by all routes investigated.  Acute oral LD50 values are reported to be in the range 2000-160000 mg/kg bw, with no mortality reported in rats administered a dose level of 5110 mg/kg bw.  No deaths were noted in rabbits following the dermal application of a dose level of 10000 mg/kg bw.  No mortality was noted in rats exposed by inhalation to 5.15 mg/L pentaerythritol dust for 4 hours and therefore the acute 4-h LC50 is > 5.15 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
25 August to 24 September 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Pentaerythritol, abbreviated to BHP in study report, provided by the Ministry of Health and Welfare (Japan), analytical purity: 92.7%. The test substance was described as a water soluble white granule, and was stored at room temperature protected from direct sunlight. The test article was confirmed to be stable for a 7 month period.
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
The animals were 4 week old male and female CrJ:CD (SD) SPF rats. Rats were purchased from Charles River Laboratories Japan, Inc and acclimatised for 9 days. Males weighed 79-86 g and females weighed 71-81 g on arrival. The rats were observed daily during the acclimatisation period, and body weights were recorded every 3 days. Only animals which showed satisfactory growth and development were selected for the experiment.
The rats were housed in a barrier-system room, maintained at a temperature of 23±3°C, humidity 55±10%, ventilation frequency 10-15 times/hour, and a 12 hour light/dark cycle. Rats were housed in groups of 5 during acclimatisation, then groups of 3 during the experiment, in metal wire-mesh floor cages.
Pelleted diet (CRF-1, Oriental Yeast Co., Ltd) and water (Sapporo tap water) were provided ad libitum. The diet and water were analysed for contaminants and found to be within the permissable ranges of the laboratory.
Individuals were identified using felt-tip marks on the base of the tail.

Rats were 5 weeks old at dosing, with an average body weight (range) of 132.5 g (125-138 g) in males and 114.0 g (108-123 g) in females.
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test substance was suspended in 0.5% carboxymethyl cellulose sodium solution (CMC-Na). A single dose was administered orally by gavage toe ach rat. The animals were fasted for approximately 17-18 hours prior to dose administration. The dosing volume was set to 10 ml per 1 kg body weight (based on the body weight taken on the day of administration).
Test substance concentrations were analytically confirmed by the Mitsubishi Gas Chemical Company, for the 1% and 20% dose preparations. The test substance concentrations were confirmed to lie within the range accepted by the laboratory (1.01-1.04% and 18.74-19.34%, respectively).
Doses:
0, 500, 1000, 2000 mg/kg
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
yes
Details on study design:
Animals were allocated to treatment groups using the body-weight stratified random sampling method. Rats were observed frequently on the day of administration, and then at least daily for 14 days. Body weights were recorded on Day 0 (dosing), Day 1, Day 3, Day 5, Day 7, Day 10 and Day 14. Rats were sacrificed for gross necropsy and histopathology (see below) after the 14 day observation period.
Statistics:
Body weight data were analysed by Bartlett's test and ANOVA followed by Dunnet's test, or Kruskal-Wallis test followed by the Mann-Whitney U test where appropriate.
Preliminary study:
Not applicable.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No mortality was observed
Clinical signs:
Rats of both sexes of the 1000 and 2000 mg/kg groups bw had diarrhoea and soft faeces on the administration day or the following day. Symptoms had disappeared 2 days after administration.
Body weight:
There were no effects of treatment upon body weight.
Gross pathology:
No abnormalites were discovered at autopsy.
Other findings:
There were no treatment-related histopathological findings. Hyaline droplet deposition in the proximal tubules of the tubular epithelium of the kidney was discovered in all male rats, including those of the control group, and was not considered to be an effect of treatment.

The acute oral LD50in male and female rats was > 2000 mg/kg bw.

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The single dose toxicity test revealed LD50 values of above 2000 mg/kg for both sexes of rat.
Executive summary:

The acute oral toxicity of pentaerythritol was determined in groups of 5 male and 5 female Crj:CD (SD) rats. Pentaerythritol (in 0.5% CMC-Na) was administered orally by gavage to fasted rats, at 0 (vehicle only), 500, 1000 or 2000 mg/kg bodyweight. Rats were observed for 14 days after dosing then submitted for gross necropsy and histopathology.

No mortalities occurred during the study. Diarrhoea and soft faeces were seen in rats from the 1000 and 2000 mg/kg bw groups on the day of administration and the day after, but symptoms as disappeared by the second day after dosing. There were no effects of treatment on bodyweight, and there were no treatment-related findings at necropsy or histpathological examination. The acute oral LD50 of pentaerythritol to rats in therefore > 2000 mg/kg bw under the conditions of this study.

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
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
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)
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.

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.
Preliminary study:
No preliminary study was reported.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 110 mg/kg bw
Quality of whole database:
Modern rat studies supported by older data in the rat and in other species

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 September to 10 November 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Version / remarks:
2014
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Pentaerythritol
- Physical state: White crystalline sold
- Analytical purity: 99.3%
- Lot/batch No.: 150602261
- Expiration date of the lot/batch: 13 June 2018
- Storage condition of test material: room temperature, in the dark
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: RccHan: WIST rats
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200-350 g
- Housing: in groups of up to five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment items: wooden chew blocks and cardboard fun tunnels (Datesand Ltd., Cheshire, UK).
- Diet: Rodent 2014C Teklad Global Certified Diet, Envigo RMS (UK) Limited, Oxon, UK, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle

IN-LIFE DATES: From: 30 September 2015 To: 03 November 2015
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
In order to facilitate aerosolisation and reduce particle size, the test item was ground using a Retsch Planetary Ball Mill (Retsch (UK) Ltd, Leeds, UK) prior to use. A dust atmosphere was produced from the test substance using a SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany) located adjacent to the exposure chamber. The SAG 410 was connected to a metered compressed air supply. Compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters before it was introduced to the SAG 410. The cylindrical exposure chamber had a volume of approximately 30 liters (dimensions: 28 cm diameter x 50 cm high). The concentration within the chamber was controlled by adjusting the test substance feed rate from the SAG 410. The extract from the exposure chamber passed through a ‘scrubber’ trap and was connected with a high efficiency filter to a metered exhaust system. The chamber was maintained under negative pressure.

One day prior to the day of exposure, each rat was acclimatized (for approximately 2 hours) to a tapered polycarbonate restraining tube. During the exposure period, each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber
and sealed by means of a rubber ‘O’ ring. Only the nose of each animal was exposed to the test atmosphere. Following an appropriate equilibration period a single group of ten rats (five males and five females) was exposed to an atmosphere of the test substance for a period of four hours. A target
concentration of 5.0 mg/L was used for the exposure. As the mean achieved concentration was 103% of target and no deaths occurred, no further levels were required.

The temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd, Beds., UK) located in a vacant port in the animals’ breathing zone of the chamber and recorded every thirty minutes throughout the four-hour exposure period. Oxygen levels within the exposure chamber were measured by an electronic oxygen analyzer (Servomex (UK) Ltd, Crowborough, East Sussex) located in a port in the animals breathing zone during the four-hour exposure period. The test atmosphere was generated to contain at least 19% oxygen.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.15 mg/L (achieved)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days. Any evidence of overt toxicity was recorded at each observation. Individual body weights were recorded on arrival, prior to treatment on the day of exposure and on Days 1, 3, 7 and 14. At the end of the fourteen day observation period the animals were killed by intravenous overdose of sodium pentobarbitone. All animals were subjected to a full external and internal examination, and any macroscopic abnormalities were recorded. The respiratory tract was subjected to a detailed macroscopic examination for signs of irritancy or local toxicity.
Statistics:
Not required.
Preliminary study:
Not applicable.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.15 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortalities occured.
Clinical signs:
other: Signs of hunched posture and piloerection are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded both during and for a short period after exposure. These observations ar
Body weight:
All animals exhibited body weight losses on the first day post-exposure. All animals exhibited body weight gains during the remainder of the recovery period.
Gross pathology:
No macroscopic abnormalities were detected amongst animals at necropsy.
Other findings:
No other findings reported.

Exposure Chamber Concentration

Atmosphere Concentration

Mean Achieved (mg/L)

Standard Deviation

Nominal (mg/L)

5.15

0.17

18.9

Particle Size Distribution

Mean Achieved Atmosphere Concentration (mg/L)

Mean Mass Median Aerodynamic Diameter (µm)

Inhalable Fraction (% <4 µm)

Geometric Standard Deviation

5.15

2.98

62.0

2.63

The chamber flow rate was maintained at 60 L/min providing 120 air changes per hour. The theoretical chamber equilibration time (T99) was 3 minutes* (Silver, 1946).

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.15 mg/L for four hours. The acute 4 hr LC50 is therefore considered to be greater than 5.15 mg/L and classification is not required.
Executive summary:

The acute inhalation toxicity of pentaerythritol was investigated in 5 male and 5 female RccHAN:WIST rats, according to OECD 403 (2009). The rats were exposed nose-only to a dust atmosphere for four-hours, followed by a 14-day observation period. The mean achieved atmosphere concentration was 5.15 mg/L (nominal 18.9 mg/L). The MMAD was determined to be 2.98 µm with a geometric standard deviation of 2.63, and the inhalable fraction (% <4 µm) was 62%. No deaths occurred. Common abnormalities noted during the study included decreased respiratory rate, increased respiratory rate, hunched posture, pilo-erection and wet fur. All animals recovered to appear normal on Day 2 post-exposure. All animals exhibited body weight losses on the first day post-exposure. All animals exhibited body weight gains during the remainder of the recovery period. No macroscopic abnormalities were detected at necropsy. No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.15 mg/L for four hours; the acute LC50 is therefore considered to be greater than 5.15 mg/L. Classification according to Regulation (EC) No 1272/2008 is not required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 150 mg/m³
Quality of whole database:
A new guideline and GLP compliant study in the rat is supported by older data

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older proprietary study also published as an abstract, scientifically acceptable.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
An acute dermal toxicity limit test was conducted in albino rabbits; the study was conducted prior to development of the guidelines, however the methodology are broadly comparable to OECD 402.
GLP compliance:
no
Remarks:
predates GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Pentaerythritol (PE 200), received from Hercules Powder Company, Inc.
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
The animals were male and female New Zealand White rabbits. The average body weight of the rabbits was approximately 2.5 kg. All rabbits had been maintained under observation in the laboratory for 7 days prior to testing. During the pre-test period, the animals were examined with respect to their general health and suitability as test animals.
The rabbits were housed in individual stainless steel cages and maintained on the standard laboratory rabbit ration. Food and water were available ad libitum.
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Twenty four hours prior to application, the abdomen of each rabbit was shaved free of hair with electric clippers. The shaved area was approximately 10% of the total body surface.
The rabbits received an application of the test material at a dose of 10 g/kg. The test material was applied as an aqueous paste. The test sites were covered by wrapping the trunk of the rabbit with an imprevious plastic sheeting which was securely taped in place.
Duration of exposure:
24 hours
Doses:
10 g/kg
No. of animals per sex per dose:
2 males and 2 females
Control animals:
not required
Details on study design:
Just prior to application of the test substance, the skin of one male and one female was abraded by making a series of epidermal incisions every 2-3 cm longitudonally over the exposure site. The incisions were sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the dermis. The skin of the other two rabbits remained intact.
Behavioural reactions were recorded during the 24 hr exposure period.
The plastic wrapping was removed from the rabbits at the end of the 24 hr exposure period. The exposure sites were examined for local reactions. Observations for mortality and behavioural abnormalities were made for a further 14 days. Special emphasis was placed on observation for skin irritation reactions at 24 and 72 hours after test material application.
Statistics:
Not applicable.
Preliminary study:
No preliminary study reported.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No mortalities occurred.
Clinical signs:
No data.
Body weight:
No data.
Gross pathology:
No data.
Other findings:
No other findings reported.

The authors state that the study provides no evidence for percutaneous absorption of pentaerythritol through intact and abraded rabbit skin, however equally the absence of findings could be interpreted as reflecting the inherently low toxicity of the substance.

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Pentaerythritol was found to be of low acute dermal toxicity. The acute dermal LD50 of pentaerythritol in rabbits was found to be >10 g/kg bw in rabbits under the conditions of this study.
Executive summary:

The acute dermal toxicity of pentaerythritol was determined in four New Zealand White rabbits (2 male and 2 female). The test sites were clipped free of hair 24 hours prior to application. Immediately prior to application, the test site of 1 male rabbit and 1 female rabbit was abraded; the other two rabbits remained intact. The test substance was applied as an aqueous paste at a dose of 10 g/kg, and held in contact with the skin for 24 hours under an impervious plastic dressing. The acute dermal LD50 of pentaerythritol in rabbits was found to be >10 g/kg bw in rabbits under the conditions of this study. The authors state that the study provides no evidence for percutaneous absorption of pentaerythritol through intact and abraded rabbit skin, however equally the absence of findings could be interpreted as reflecting the inherently low toxicity of the substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

Acute oral toxicity

Pentaerythritol was evaluated for acute toxicity after single oral administration in rats in a GLP study, according to OECD method 401 (Berthold, 1990). The test substance was suspended in 1% aqueous tylose and administered by gavage at a dose of 5110 mg/kg bw. The only clinical sign observed was diarrhoea, recorded in all rats at 7 hours after administration. There were no deaths during the 14 day observation period, and there were no abnormal findings at necropsy. The acute oral LD50 was therefore greater than 5110 mg/kg for male and female rats. Yahata (1996) also evaluated the acute oral toxicity of pentaerythritol in a GLP study according to OECD 401, conducted with groups of 5 male and 5 female Crj:CD (SD) rats. Pentaerythritol in 0.5% CMC-Na was administered by gavage at doses of 0 (vehicle only), 500, 1000 or 2000 mg/kg bodyweight. Rats were observed for 14 days after dosing, then subject to gross necropsy and histopathology. No rats died during the study. Diarrhoea and soft faeces were observed in rats from the 1000 and 2000 mg/kg bw groups on the day of administration and the following day. There were no effects on bodyweight, and there were no treatment-related findings at necropsy or histopathological examination. The acute oral LD50 was therefore estimated to be greater than 2000 mg/kg. Keplinger & Kay (1964) present acute toxicity data for pentaerythritol in a conference abstract. Methodological information is not available, however the data support the results obtained in the more recent studies. The acute oral LD50 of pentaerythritol in guinea pigs is reported to be 11300 mg/kg, and in mice it was 25500 mg/kg bw. Lethal doses in rats caused ataxia, tremors, and loss of righting reflex. Necropsies of rats revealed no pathologic changes attributable to pentaerythritol. Doses greater than 5000 mg/kg bw caused diarrhoea for 12 -36 hours, and it was reported that rats survived doses at high as 16000 mg/kg bw.

Acute inhalation toxicity

A recent, guideline (OECD 403) and GLP compliant study was conducted in male and female rats (Griffiths, 2015). The rats were exposed nose-only to a dust atmosphere of pentaerythritol for 4 hours and observed for 14 days. The mean achieved concentration was 5.15 mg/L pentaerythritol, and 62% of particles were in the inhalable fraction (< 4 µm). No deaths occurred, and clinical observations were limited to common abnormalities associated with nose-only inhalation exposure and restraint, and all animals recovered by Day 2 post-exposure. The acute 4-hour LC50 of pentaerythritol in the rat was considered to be greater than 5.15 mg/L. Keplinger & Kay (1964) also reported that exposure of rats to 11 g/m³ pentaerythritol dust for a single 6 hour period caused no adverse effects.

Acute toxicity: dermal

The acute dermal toxicity of pentaerythritol was determined in four New Zealand White rabbits (Palazzolo & Kay, 1963). The test sites were clipped free of hair 24 hours prior to application. Immediately prior to application, the test site of 1 male rabbit and 1 female rabbit was abraded; the other two rabbits remained intact. The test substance was applied as an aqueous paste at a dose of 10 g/kg, and held in contact with the skin for 24 hours under an impervious plastic dressing. The acute dermal LD50 of pentaerythritol in rabbits was found to be >10 g/kg bw in rabbits under the conditions of this study. The authors state that the study provides no evidence for percutaneous absorption of pentaerythritol through intact and abraded rabbit skin, however equally the absence of findings could be interpreted as reflecting the inherently low toxicity of the substance.

.

Justification for selection of acute toxicity – oral endpoint
Modern, guideline study performed in the preferred species; full report available

Justification for selection of acute toxicity – inhalation endpoint
Modern, guideline GLP study.

Justification for selection of acute toxicity – dermal endpoint
Only one study available for this endpoint

Justification for classification or non-classification

Pentaerythritol is of low acute toxicity by all routes investigated. No classification is required according to CLP Regulation 1272/2008.