11-aminoundecanoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2c: comparable to guideline study with acceptable restrictions. No GLP procedure. No data on purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

11-aminoundecanoic acid

EC Number:

219-417-6

EC Name:

11-aminoundecanoic acid

Cas Number:

2432-99-7

Molecular formula:

C11H23NO2

IUPAC Name:

11-aminoundecanoic acid

Details on test material:

- Name of test material (as cited in study report): omega amino-undecanoic acid
no other data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO stock (L'arbrèle, France)
- Strain OFA and SPF quality
- Age at study initiation: no data
- Weight at study initiation: male 175 g / females 164 g and 147 g for every two groups of 5 animals tested respectively
- Fasting period before study: water diet for about 18h prior to administration
- Housing: 2 to 5 animals per cage containing litter consisting of sterilised de-dusted wood shavings(cage dimensions: 25 x 16 x 13 cm)
- Diet ad libitum with SOURISFFARAT
- Water ad libitum
- Acclimation period: animals were kept under the same housing conditions as those applied during their breeding
ENVIRONMENTAL CONDITIONS
no data

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and ventral regions.
- mean of application: 24h before exposure the 3 groups of animals were shaven for their dorsal and ventral regions (electric chaver ESCULAP).
In addition animals of the group III were scarified using a vaccination style, 8 incisions were made 4-6 cm long and about 0.5 cm appart
The regions were previously dampened with sterile water before application of the substance.
The coverage consisted of a bangage comprising a sheet of aluminium foil with strips of adhesive plaster.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data.
- Time after start of exposure: 24h after application the protective bandange was removed

TEST MATERIAL
- Amount(s) applied:
. groupe I: 1g/kg bw
. groupe II: 2 g/kg bw
. groupe III (scarified): 2
- For solids, paste formed: no data

Duration of exposure:

24h

Doses:

. groupe I: 1g/kg bw
. groupe II: 2 g/kg bw
. groupe III (scarified): 2 g/kg bw

No. of animals per sex per dose:

5 animals per sex per group (two doses tested but one duplicated on scarified skin)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 1, 2, 4, 7 and 14
- Necropsy of survivors performed: no
- Other examinations performed: body weight, behaviour

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Mortality:

no death occurred

Clinical signs:

other: no behavioural anomaly

Any other information on results incl. tables

Table 1: Body weight in males and females for the 14 days following application

	day 0	day 2	day 7	day 14
group I (male / female)	181 / 176	180 / 178	214 / 210	260 / 238
group II   (male/ female)	179 / 184	181 / 179	223 / 201	263 / 232
group III (male/ female)	208 / 206	168 / 190	223 / 212	269 / 238

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

Under the tested conditions, 11 aminoundecanoic acid is not toxic to rats. Therefore the substance is not classified according to EU and GHS recommendations.

Executive summary:

In an acute dermal toxicity study (IFREB, 1978), 3 groups of Sprague-Dawley rats composed of 5 males and 5 females each were tested for a single application of 11- aminoundecanoic acid at a dose of 1000 mg/kg bw and 2000 mg/kg bw for 24h under an occlusive patch (bandage = aluminium sheet + adhesive plaster).

All animals were shaven and application made on intact skin for group I and II at doses of 1 and 2 g/kg bw respectively. In group III tested with 2g/kg w, the skin was shaven and scarified. All groups were observed for 14 days.

No death occured and no behavioural anomaly was recorded throughout the 14 days of the test.

LD0 = 2000 mg /kg bw in rats in combined sex.

11 aminoundecanoic acid is therefore not classified according to EU and GHS classifications.