Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
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

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
Details on test material:
Pentaerythritol (PE 200), received from Hercules Powder Company, Inc.
Specific details on test material used for the study:
Pentaerythritol (PE 200), received from Hercules Powder Company, Inc.

Test animals

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.

Administration / exposure

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.

Results and discussion

Preliminary study:
No preliminary study reported.
Effect levels
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.