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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

Constituent 1
Chemical structure
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.