Fatty acids, C16-18, esters with pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

January 04th, 1996 - February 01th, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only basic data on study substance given

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: clear, yellowish liquid
- Analytical purity: Not specified
- Purity test date: Not specified
- Lot/batch No.: 1043
- Stability under test conditions: Not specified
- Storage condition of test material: RT

Test animals

Species:

rat

Strain:

other: Hsd/Cpb:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: Not specified
- Weight at study initiation: 212 - 220 g for males and 165 - 205 g for females
- Housing: 5 animals per Makrolon type III cage
- Fasting period before study: 16 h before until 3 - 4 h after dosing
- Diet (e.g. ad libitum): ad libitum (Ssniff-R Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.15 ml/kg

Doses:

2000 mg/kg bw taking into account the specific gravity of 0.93 g/ml

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: 10 min, 1 h, 6 h, 24 h, and thereafter once daily up to 14 d, weighing on days 0, 7 and 14
- Necropsy of survivors performed: yes, by CO2 asphyxiation
- Other examinations performed: gross pathology

Statistics:

Not applicable

Results and discussion

Preliminary study:

Single application of 2000 mg/kg bw in two female rats.
No deaths occurred.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No abnormal clinical signs

Gross pathology:

No apparent abnormalities. Macroscopic changes that were observed were attributed to minor variations which can occur spontaneously in rats of this strain and age.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU