Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
no behavioural anomaly
Body weight:
The more significant weight loss was observed in group III.
This change in body weight was transient and was considered to be related to the fact that animals are constrained (See table 1 in the results freetext). This variation in body weight was not considered to be related to the treatment with the test item.

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.