12-aminododecanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 July 2007 - 30 July 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

12-aminododecanoic acid

EC Number:

211-754-7

EC Name:

12-aminododecanoic acid

Cas Number:

693-57-2

Molecular formula:

C12H25NO2

IUPAC Name:

12-aminododecanoic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Description: white powder
Storage conditions: approximately 4 °C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: The bodyweight variation did not exceed ± 20 % of the initial mean bodyweight of any previously dosed animal(s)
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum. Free access to food (Certified Rat and Mouse Diet) was allowed throughout the study
- Water (e.g. ad libitum): ad libitum mains drinking water
The 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.
- Acclimation period: at least five days
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25 °C
- Humidity (%): 30 – 70 % relative
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Experimental Preparation
For the purpose of the study the test material was freshly prepared, as required, as a suspension in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.

Doses:

A single dose of 2000 mg/kg (dose volume 10 mL/kg)

No. of animals per sex per dose:

A total of 5 female animals were dosed at 2000 mg/kg with a dose volume of 10 mL/kg

Control animals:

no

Details on study design:

Procedure
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.

Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (mg/mL) (mL/kg) Female
2000 200 10 1
In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:

Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (mg/mL) (mL/kg) Female
2000 200 10 4

A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen 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 the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Evaluation of data included identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. If possible, the signs of evident toxicity were described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on bodyweights and abnormalities noted at necropsy were also identified

Results and discussion

Preliminary study:

A single animal, dosed at 2000 mg/kg, did not show overt signs of toxicity following a single exposure to the test material. An additional group of animals was subsequently dosed at the same level.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: No signs of systemic toxicity were noted

Gross pathology:

No abnormalities were noted at necropsy

Any other information on results incl. tables

Table 1: Individual Bodyweights and Bodyweight Changes

Dose level	Animal number and sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2000	1-0 F	220	243	262	23	19
	2-0 F	215	237	259	22	22
	2-1 F	239	267	283	28	16
	2-2 F	243	271	291	28	20
	2-3 F	220	241	280	21	39

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the LD50 of the test material was estimated to be greater than 2000 mg/kg bw.

Executive summary:

The acute oral median lethal dose (LD50) of the test material in female Sprague-Dawley rats was estimated to be greater than 2000 mg/kg bodyweight.

The method was designed to meet the requirements of the OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001) and Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC.