Fatty acids, C8-10, tetraesters with pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions. (Lack of data on test material.)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

adopted in 2008

Deviations:

yes

Remarks:

lack of data on test material

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid

EC Number:

275-118-0

EC Name:

Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid

Cas Number:

71010-76-9

IUPAC Name:

71010-76-9

Details on test material:

- Physical state: clear colorless liquid
- Analytical purity: no data
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 214 - 223 g
- Fasting period before study: animals were fasted over night prior to administration.
- Housing: animals were group housed upon receipt and individually housed upon assignment to study in compliance with the National Research Council "Guide for the Care and Use of Laboratory Animals".
- Diet: Harlan Teklad Rodent Diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 23 - 59
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 10 Jan 2006
To: 26 Jan 2006

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Up-and-Down Procedure: The first animal was dosed at an initial dose level of 2000 mg/kg bw. Since this animal survived, four additional females received the test substance at 2000 mg/kg bw.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed prior to dosing, approximately 30 min and 4 h post-dose as well as once daily on Days 2 to 15. Animals were weighed prior to dosing on Day 1 and on Day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality/morbidity (once daily)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

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