Fatty acids, coco, isotridecyl esters

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

Study period:

27 May - 09 Jun 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions. The analytical purity of the test substance was not specified; necropsy was not performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

necropsy not performed

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

yes

Remarks:

necropsy not performed

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctadecyl palmitate

EC Number:

276-719-0

EC Name:

Isooctadecyl palmitate

Cas Number:

72576-80-8

IUPAC Name:

72576-80-8

Details on test material:

- Name of test material (as cited in study report): palmitate d'isostearyle
- Physical state: clear liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature in sterile bottle

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 220.7 - 243.6 g (males) and 199.0 - 216.0 g (females)
- Fasting period before study: animals were fasted for 24 hours prior to dosing
- Housing: animals were housed 5 per cage in polycarbonate cages (450mm x 300mm x 200mm), which had a type E wire floor and contained absorbent material
- Diet: feed A04 (U.A.R., Epinay Sur Orge, France), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-75
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 May 1999 To: 9 Jun 1999

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and clinical signs immediately, 15 mins and 6 hours after administration, and daily thereafter (5 days per week); animals were weighed on Day 0, 7 and 14
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality or clinical signs were observed at this dose level.

Mortality:

There was no mortality during the study period.

Clinical signs:

other: No clinical signs were observed during the 14-day study period.

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