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Toxicological information

Acute Toxicity: oral

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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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
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'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:
2h : no anomaly observed
6h : reduction of spontaneous activity and hair erection
day 2: heavy emission of urine
Body weight:
no data
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
 20  50  10.0 ♂ 156 / ♀ 154 2/2 0/ 0/ 0/ 0/ 0/ 0/ 0/ 0/
 30 50  15  ♂  175 / ♀ 164  5/5 0/ 0/ 0/ 0/ 0/ 0/ 0/ 0/ 10% 
 30  50 15  ♀ 147  5

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.