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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:
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)
Version / remarks:
(2001)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of fatty acids, C16 and C16-18 (even numbered, unsaturated) alkyl and adipic acid with pentaerythritol
EC Number:
923-900-3
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Esterification products of fatty acids, C16 and C16-18 (even numbered, unsaturated) alkyl and adipic acid with pentaerythritol
Test material form:
liquid
Specific details on test material used for the study:
Stability in vehicle analytically confirmed.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: HsdCpb:Wu
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: 8-12 weeks approximately
- Weight at study initiation: 166-194 g
- Fasting period before study: Food was withheld from the animals for approximately 16-24 h before administration of the test item, and they were fed again approximately 2-4 h after administration.
- Housing: The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
paraffin oil
Details on oral exposure:
Administration volume: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 animals per step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily. The weight gain was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
Statistics:
The LD50 value was estimated according to OECD TG 423 (2001).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Remarks on result:
other: cut-off level according to OECD TG 423, Annex 2d
Mortality:
There were no deaths.
Clinical signs:
other: No clinical signs were observed.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to the Acute Toxic Class Method (OECD TG 423) was performed on 6 female rats (3 per step), receiving each a single dose of 2000 mg/kg of the test item formulated in paraffin oil. No mortalities, no clinical signs, no effects on body weight gain and no gross pathological findings were observed. The LD50 of the test material was estimated from the flow chart of the OECD TG 423, Annex 2d, to be >/= 5000 mg/kg bw.