Fatty acids, C16 and C16-18-unsatd., mixed esters with adipic acid and pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 Mar - 28 Mar 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP 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)

Version / remarks:

adopted in 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered) and C18-unsatd., adipic acid esters with pentaerythritol

EC Number:

921-836-0

Cas Number:

1190402-12-0

Molecular formula:

not available, UVCB substance

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18-unsatd., adipic acid esters with pentaerythritol

Details on test material:

- Name of test material (as cited in study report): [trade name]
- Physical state/appearance: dark liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Calco (LC)
- Weight at study initiation: 195 - 214 g
- Housing: 3 per cage in polycarbonate cages
- Diet: standard pellet complete diet (Harlan Laboratories); ad libitum
- Water: purified water; ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: before administration, on day 7 and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, observation of organic bodies functions, evaluation of tegumentary aparatus, evaluation of mucous conditions, evaluation of somatomotor activity and sensorial conditions.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 experimental

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Mortality:

No mortality occurred during the observation period.

Clinical signs:

other: No abnormalities were detected during the study.

Gross pathology:

- Group I: Slight mucous enteritis of the intestinal tract was observed in one animal.
- Group II: No abnormalities were detected.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified