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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

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.