Chlorinated Fatty Acid Methyl Ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17 December 2001

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl tetradecanoate, chloro

Molecular formula:

C13H26Cl4COOCH3 and C13H25Cl5COOCH3 (primary isomers based on product weight of 35-40% Cl by weight)

IUPAC Name:

methyl tetradecanoate, chloro

Constituent 2

Reference substance name:

Methyl octadecanoate, chloro

Molecular formula:

C17H30Cl4COOCH3, C17H29Cl5COOCH3 , and C17H28Cl6COOCH3 (primary isomers based on 35-40% Cl by weight)

IUPAC Name:

Methyl octadecanoate, chloro

Constituent 3

Reference substance name:

Methyl hexadecanoate, chloro

Molecular formula:

C15H28Cl4COOCH3 and C15H27Cl5COOCH3 (primary isomers based on 35-40% Cl by weight)

IUPAC Name:

Methyl hexadecanoate, chloro

Test material form:

liquid

Details on test material:

This is a UVCB substance developed from the chlorination of fatty acid methyl esters.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanRcc:WIST (SPF)

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a dosing volume of 10 ml/kg.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females, 3 per group, all tested at limit (2000 mg/kg bw) dose

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None

Clinical signs:

The first three treated animals showed a slightly ruffled fur from the 30-minute or 1-hour reading to the 5-hour reading. Hunched posture was present in the same animals from the 1 to the 3-hour reading. The three further animals did not show any clinical signs.

Body weight:

The body weights of the animals were within the range commonly recorded for this strain and
age.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Conclusions:

Based on the results of the study, the LD50 for C16 and C18 chlorinated methyl esters is considered to be >2000 mg/kg bw.

Executive summary:

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with DA 8506 (C16 and C18 chlorinated methyl esters) by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a dosing volume of 10 ml/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.

Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period.

The first three treated animals showed a slightly ruffled fur from the 30-minute or 1-hour reading to the 5-hour reading. Hunched posture was present in the same animals from the 1 to the 3-hour reading. The three further animals did not show any clinical signs. No macroscopic findings were recorded at necropsy.

Based on the results of the study, the LD50 is considered to be >2000 mg/kg bw.