Fatty acids, tall-oil, reaction products with pentaethylenehexamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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:

Fatty acids, tall-oil, reaction products with pentaethylenehexamine

EC Number:

288-927-9

EC Name:

Fatty acids, tall-oil, reaction products with pentaethylenehexamine

Cas Number:

85940-40-5

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Fatty acids, tall-oil, reaction products with pentaethylenehexamine

Test material form:

liquid: viscous

Details on test material:

viscous liquid
UVCB

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 160-250g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
- Fasting: 16h before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 13, 2012 To: October 2nd, 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw, 2.13 ml/kg bw

DOSAGE PREPARATION (if unusual): For a better homogeneity the test item was heated at 40°C for approx. 1 hour. The test item was administrated hand warm.

Doses:

single administration of 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually for behaviour changes or signs of toxicity <0.5, 1, 2, 3, 4 and 5 hours after dosing at the day of administration and at least once daily thereafter. Clinical observations were performed at least once each workday and recorded individually. Individual body weight was determined shortly before test item administration, at approx. weekly intervals thereafter and before the sacrifice of the animals at the end of the observation period. A check for moribund and dead animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: On the last day of the observation period, the animals were sacrificed by CO2-inhalation in a chamber with increasing concentrations over time, followed by necropsy and gross-pathological examination.

Statistics:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occured

Clinical signs:

other: Impaired general state, dyspnoea, piloerection (first test group); no signs (second group)

Gross pathology:

There were no macroscopic pathological findings at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met