Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-417-6 | CAS number: 2432-99-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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. The report is succinct and no record of eventual loss of weight is studied but the study is similar to OECD guideline requirements (401) but not performed according to GLP procedure.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- before GLP publication
- Test type:
- standard acute method
- Limit test:
- no
Test material
- 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
Constituent 1
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'arbresle, 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: 43 x 30 x 18 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
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): 30mL
MAXIMUM DOSE VOLUME APPLIED: 30mL/kg
concentration tested : 15g/kg (50% diluted)
- Doses:
- - 1, 5 and 10 g/kg bw (preliminary test)
- 15 g/kg bw (definitive test) - No. of animals per sex per dose:
- - 2 animals per sex per dose (preliminary test)
- 5 animals per sex per dose and then again 5 females (definitive test) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: after 1h, 2h, 8h, day 1, day 2 day 4, day 7 and day 14
- Necropsy of survivors performed: no
- Other examinations performed: behaviour, no record of bodyweight at the end on the test (only before administration), no data about necropsy of dead animals during the study - Statistics:
- no statistics were performed.
Results and discussion
- Preliminary study:
- no mortality was observed
see table 1 in result freetext
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 15 000 mg/kg bw
- Mortality:
- 2 deaths were observed on day 7 and day 14 for the highest concentration tested
see table 1 in the result freetetxt - Clinical signs:
- other: 2h : no anomaly observed 6h : reduction of spontaneous activity and hair erection day 2: heavy emission of urine
- Gross pathology:
- no data
- Other findings:
- - Organ weights: no data
- Histopathology: no data
- Potential target organs: no data
- Other observations: no data
Any other information on results incl. tables
table 1: detail of the cumulative mortality observed during the preliminary test (1 , 5 and 10 g/kg bw doses) and during the definitive test (15 g/kg bw)
| administration | animals | cumulative mortality | |||||||||||
| vol (ml/kg) | conc. (%) | dose (g/kg) | weight (g) | number | 1h | 2h | 8h | day 1 | day 2 | day 4 | day 7 | day 14 | % |
| 2 | 50 | 1.0 | ¿ 175 / ¿ 164 | 2/2 | 0 / 0 | 0 / 0 | 0 /0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 |
| 10 | 50 | 5.0 | ¿ 153 / ¿ 149 | 2/2 | 0/0 | 0/ 0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0 |
| 20 | 50 | 10.0 | ¿ 156 / ¿ 154 | 2/2 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0 |
| 30 | 50 | 15 | ¿ 175 / ¿ 164 | 5/5 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/1 | 0/1 | 10% |
| 30 | 50 | 15 | ¿ 147 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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 oral toxicity study, groups of fasted Sprague-Dawley rats (5 males and 2x 5 females) were given a single oral dose of omega amino-undecanoic acid at 15000 mg/kg bw and were observed for 14 days. Only one death occured in the first groups of females tested six days after administration. This death has not been linked to the treatment administered, especially since the other rats were not affected by any important behavioural anomaly throughout the fourteen days of observation of the test. A further group of 5 females was subjected to the same dose. No death occured nor behavioural anomaly. LD0 = 15000 mg /kg bw in rats in combined sex.
Under the conditions of this test, 11 aminoundecanoic acid is therefore not classified according to EU and GHS classifications.
This acute oral study is classified as reliable with restriction considering that the report is succinct and no record of eventual loss of weight is studied but it is similar to OECD guideline requirements (OECD 401) even if not performed according to GLP procedure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
