Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-10-06 to 2011-11-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 9-decenoic acid, methyl ester (9DAME)
- Physical state: Clear colourless liquid
- Purity: 99%
- Lot/batch No.: 184-109
- Date received: 2011-04-01
- Storage condition of test material: Room temperature in the dark under nitrogen

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 164 ± 20 %
- Fasting period before study: Overnight immediately prior to dosing and 3-4 hours after dosing
- Housing: Groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Free access to 2014C Teklad Global Rodent Diet supplied by Harlan Laboratories UK Ltd, Oxon, UK
- Water: Free access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 ºC
- Humidity: 30 to 70 %
- Air changes: At least 15
- Photoperiod: 12 hours light (06:00 to 18:00) and 12 hours dark controlled by a time switch

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
300 mg/kg dose level
Details on oral exposure:
EXPERIMENTAL PREPARATION
- Specific gravity of the test material was determined and used to calculate the appropriate dose volume.
- The test material was formulated within two hours of being applied to the test system and it was assumed that the substance was stable for that period of time.
- No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation and that decision was noted in the GLP compliance statement.
Doses:
- Initial investigation: single dose of 300 mg/kg as a dose volume of 10 mL (30 mg/mL).
- Second investigation: single dose of 2000 mg/kg (2.26 mL/kg; specific gravity 0.885).
- Third investigation: single dose of 2000 mg/kg (2.26 mL/kg; specific gravity 0.885).
No. of animals per sex per dose:
- Initial investigation: one
- Second investigation: one
- Third investigation: four
Control animals:
no
Details on study design:
ANIMALS AND ANIMAL HUSBANDRY
- Animals were randomly allocated to cages on receipt.
- The females were nulliparous and non-pregnant.
- Animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
- Diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
- Animals were provided with environmental enrichment items that were considered not to contain any contaminant at a level that could affect the purpose or integrity of the study.

PROCEDURE
- In the absence of data on test material toxicity, 300 mg/kg was chosen as the starting dose.
- In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was treated.
- In the absence of mortality at a dose level of 2000 mg/kg, a further group of animals was treated.
Statistics:
- Data evaluations included the relationship, if any, between the animals' exposure to test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
- Motality data was used to obtain an estimate of the acute oral median lethal dose (LD50) of the test material.

Results and discussion

Preliminary study:
- No toxicity was observed at a dose level of 300mg/kg
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at a dose level of 300 mg/kg or 2000 mg/kg
Clinical signs:
- No signs of clinical toxicity were noted during the observation period following treatment at 300 mg/kg or 2000 mg/kg
Body weight:
The animal showed expected gains in bodyweight over the observation period at 300 mg/kg and 2000 mg/kg
Gross pathology:
No abnormalities were noted at necropsy following dosing at 300 mg/kg and 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
(EU CLP)
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.