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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
may 1976 to august 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2e: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
yes
Remarks:
hematological, clinical biochemistry, urine analysis and FOB were not performed and daily intake, clinical signs, food consumption, and organ organ weights were not reported.
GLP compliance:
not specified
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): 11-aminoundecanoic acid
- Physical state: white cristalline
- Analytical purity: 99.13 ± 0.03 wt%
- Lot/batch No.: 503
no other data

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: NCI Frederick Cancer Research Center
- Age at study initiation: five-week old
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: four per cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: Two weeks


ENVIRONMENTAL CONDITIONS
no data


IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: Test diets were prepared by first mixing a small amount of Purina Lab Chow and the required amount of 11-aminoundecanoic acid with a mortar and pestle and then adding this premix to the required amount of animal meal and mixing for 20 minutes in a Patterson-Kelly twin shell blender equipped with an intensifier bar. Prepared diets containing 100,000 ppm 11-aminoundecanoic acid were analyzed at Midwest Research Institute and were found to be stable for 2 weeks at temperatures up to 45°C. Test diet were stored in the dark at 4°C for no longer than 2 weeks.


DIET PREPARATION
- Rate of preparation of diet (frequency): at least every two weeks.
- Mixing appropriate amounts with (Type of food): Purina Lab Chow
- Storage temperature of food: in the dark at 4°C


Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
continuous
Doses / concentrations
Remarks:
Doses / Concentrations:
0; 9,000; 12,000; 15,000; 18,000; 20,000
Basis:
nominal in diet
No. of animals per sex per dose:
10 per sex per dose
Control animals:
yes, plain diet
Details on study design:
- Dose selection rationale: no data
- Rationale for animal assignment (if not random): Mice were randomized by weight and assigned to test groups so that average cage weights were approximately equal for all animals of the same sex and species.
Positive control:
No

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No


CLINICAL CHEMISTRY: No


URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Other examinations:
No
Statistics:
no statistics were performed.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
CLINICAL SIGNS AND MORTALITY: Deaths occured in 2/10 male and 2/10 female mice administered 15,000 ppm, 4/10 males and 2/10 females receiving 18,000 ppm, and 3/10 males receiving 20,000 ppm. The cause of death of animals dying during the study was not determined.

BODY WEIGHT AND WEIGHT GAIN: Mean body weight gain was depressed 20 % in male mice receiving 15,000 ppm, but only 10 % in male mice receiving 18,000 or 20,000 ppm. Mean body weight gain was depressed by more than 10 % in female mice fed diets containing 18,000-20,000 ppm 11-aminoundecanoic acid.

HISTOPATHOLOGY: NON-NEOPLASTIC: Focal mineralization of the kidney was noted in males that received 15,000-20,000 ppm and in females that received 15,000-18,000 ppm, particulary in males that received 15,000-20,000 ppm and in females that received 15,000-18,000 ppm, particulary in those mice that died.


Effect levels

Dose descriptor:
NOAEL
Effect level:
9 000 ppm
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test, deaths occured in mice administered with doses above 15,000 ppm in male and female mice.The administration of up to 20,000 ppm 11-aminoundecanoic acid in the diet of mice for 13 weeks leads to focal mineralisation of the kidneys and body weight depression.
Executive summary:

In a 91-day oral range finding studies in mice (NTP, 1982), five-week-old male and female B6C3F1 mice were fed with diets containing 0, 9,000, 12,000, 15,000, 18,000 or 20,000 ppm 11-aminoundecanoic acid. Groups of 10 male and 10 female mice were used. Animals were checked for mortality and signs of mortality. Each animal was given a clinical examination weekly, including palpation for tissue masses or swelling body weight and feed consumption data were collected weekly. Deaths occured in 2/10 males and 2/10 females administered 15,000 ppm, 4/10 males and 2/10 females receiving 18,000, and 3/10 males receiving 20,000 ppm. The cause of death of animals dying during the study was not determined. Mean body weight gain was depressed 20 % in male mice receiving 15,000 ppm, but only 10 % in male receiving 18,000 or 20,000 ppm. Mean body weight gain was depressed by more than 10 % in female mice fed diets containing 18,000 -20,000 ppm 11 -aminoundecanoic acid. Focal mineralization of the kidney was noted in males that received 15,000 -20,000 ppm and in females that received 15,000-18,000 ppm, particularly in those mice that died. The NOAEL was estimated to be 9000 ppm.