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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Heptadecanol, branched and linear
EC Number:
291-378-8
EC Name:
Heptadecanol, branched and linear
Cas Number:
90388-00-4
Molecular formula:
C17H36O
IUPAC Name:
2-methylhexadecan-1-ol; heptadecan-1-ol
Details on test material:
Name of the test substance used in the study report: HEPTADECANOL N
Purity: 99.8%

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Age when treated: 11 weeks
Body weight when treated: 180 - 189 g
The rats were identified using unique cage number and corresponding color-coded spots on the tail.
The animals were housed in air-conditioned rooms with a room temperature of 22 +/°C and a relative humdity between 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
Three animals per cage (type Makrolon 4 with wire mesh tops and standard softwood bedding).
The rats were offered a standardized laboratory diet as well as tap water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE:
Yellowish oily liquid
Batch Number: 24788186
Source: Carl Roth GmbH & Co., 76185 Karlsruhe / Germany
Stability: Stable under storage conditions
Expiry Date: 30-Nov-2012
Storage Conditions: At room temperature (range of 20 ± 3°C), light protected.
Safety Precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Olive oil was found to be a suitable vehicle.

TEST ITEM:
Dosing volume: 10 m l/kg b.w.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 (2 test groups)
Control animals:
no
Details on study design:
Clinical signs: Daily during the acclimatization period, during the first 30 min and approx. 1, 2, 3 and 5 h after administration on test day 1, depending on the occurrence of clinical signs of toxciity. Once daily during days 2 - 15.
Body weight: On tst day 1 (prior to administration), 8 and 15.
Viability/Mortality: Daily during the acclimatization period, during the first 30 min and at approx. 1, 2, 3 and 5 h after administration on test day 1 (in common with the clinical signs) and twice daily during days 2 - 15.
Necropsy: All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained.
Observation period: 15 days

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no deaths
Mortality:
none
Clinical signs:
other: none
Gross pathology:
Nothing abnormal detected.

Applicant's summary and conclusion