Pentatriacontan-18-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentatriacontan-18-one

EC Number:

207-993-1

EC Name:

Pentatriacontan-18-one

Cas Number:

504-53-0

Molecular formula:

C35H70O

IUPAC Name:

pentatriacontan-18-one

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species Wistar rats
Source Dobrá Voda, Slovak Republic
Number and Sex of Animals 6 females
Age at First Dose 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to t he start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning. The average room temperature was maintained within the range of 22 ± 3 °C, relative humidity within 50-60%. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was p erformed according to the standard operation procedures.
Diet The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approxi mately at the same time. The certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Drinking water was supplied ad libitum. The quality of drin king water is periodical analysed and recorded; certificate of analysis is included in the raw data.
Bedding Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the test item.
Justification for the Choice of Species Normally females are used for testing OECD TG 423 because females are typically the more sensitive gender.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was therefore used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose level.

No. of animals per sex per dose:

6

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight

Clinical signs:

other: Sex Dose ID Administration Result Clinical Observation ♀ 2000 mg/kg 1 alive no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period 2 alive no signs of intoxication, change

Other findings:

All animals were necropsied. During necropsy, no macroscopic findings were observed. Table 3 Necropsy Results
Sex Dose ID Result Sex Dose ID Result
♀ 2000 mg/kg 1 no findings ♀ 2000 mg/kg 4 no findings
2 no findings 5 no findings
3 no findings 6 no findings

Any other information on results incl. tables

The LD50 of the test item Stearone is greater than 2000 mg/kg body weight after single oral

administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD

Guideline 423 it can be concluded that the test item Stearone is classified in GHS Category 5 or

Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single

oral administration to Wistar rats.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Stearone is greater than 2000 mg/kg body weight after single oral
administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD
Guideline 423 it can be concluded that the test item Stearone is classified in GHS Category 5 or
Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single
oral administration to Wistar rats.

Executive summary:

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. 

Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test itemrelated mortality was not observed during 24 hours and therefore in a next step, 3 females were treated with the same dose. All 6 females survived the limit dose. 

The test item Stearone was administered to 6 female Wistar rats at a limit dose of 2000 mg/kg. The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed. The body weight of animals mildly increased during the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. 

The LD₅₀of the test item Stearone is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based onAnnex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423it can be concluded that the test item Stearone is classified in GHS Category 5 or Unclassified with a LD₅₀cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.