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Administrative data

Description of key information

• Oral LD50 > 2000 mg/kg bodyweight (OECD 420)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes
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
- 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 changes per hour
- Photoperiod: 12 hours light (06:00 to 18:00) and 12 hours dark controlled by a time switch
Route of administration:
oral: gavage
Vehicle:
other: Arachis oil BP
Details on oral exposure:
EXPERIMENTAL PREPARATION
- 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.

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Dosage volume: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
- Initial investigation: one female
- Second investigation: four females
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
- Using available information on the toxicity of the test item, 2000 mg/kg was chosen as the starting dose.
- In the absence of mortality at a dose level of 2000 mg/kg, an additional group of 4 animals was treated at a dose level of 2000 mg/kg.
- All animals were dosed once only by gavage.
- The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

OBSERVATIONS
- Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 4 days.
- Morbidity and mortality checks were made twice daily.
- Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- At the end of the observation period all animals were subjected to gross necropsy consisting of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
- Motality data was used to obtain an estimate of the acute oral median lethal dose (LD50) of the test material.
Preliminary study:
No mortality occurred at the preliminary dose level of 2000 mg/kg.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
No signs of systemic toxicity were noted.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the test material was assessed according to OECD Guideline 420. 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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
All studies conducted to GLP and OECD guidelines.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

A reliable study was performed in accordance with GLP and OECD Guideline 420 to assess the acute oral toxicity of octadecanedioic acid, 1,18-dimethyl ester (ODDAME) in the female Wistar strain rat (Harlan Laboratories Ltd, 2013). Following an initial test in one animal at a dose level of 2000 mg/kg, a further group of four fasted animals was given a single oral dose of the test item at a dose level of 2000 mg/kg bw. There were no mortalities or signs of systemic toxicity during the study. All animals showed expected gains in bodyweight and no abnormalities were noted at necropsy. The acute oral LD50 of octadecanedioic acid, 1,18-dimethyl ester (ODDAME) in the female Wistar strain rat was therefore estimated to be greater than 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Key study performed in accordance with GLP and OECD Guideline 420 and suitable for classification and labelling.

Justification for classification or non-classification

The acute oral LD50 in rats for octadecanedioic acid, 1,18-dimethyl ester (ODDAME) was > 2000 mg/kg bw. Therefore, this substance does not require classification for acute oral toxicity according to the criteria described in Regulation (EC) No 1272/2008.