Registration Dossier

Administrative data

Description of key information

Oral: LD50 = 14700-21500 mg/kg bw for female rats (equivalent to OECD Guideline 401)
LD0 >21500 mg/kg bw for male rats (equivalent to OECD Guideline 401)
Dermal: LD0 >2000 mg/kg for female and male rats (equivalent to OECD Guideline 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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.
Preliminary study:
no mortality was observed
see table 1 in result freetext
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

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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
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
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
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
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.

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 
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity:

Two studies are reported for this endpoint. The first (IFREB, 1978), chosen as key study, consists in a limit test (similar to OECD TG 401) with male and female Sprague-Dawley rats. 11 -aminoundecanoic acid was administered orally in a single 15 g/kg bw dose to a group of 10 animals (5 males, 5 females) and then again to 5 females. Results showed no death linked to the treatment administered. Moreover, no relevant change in appearance and behaviour was observed throughout the fourteen days of the test. Under the conditions of this test, it appears that the LD0 of 11 -aminoundecanoic acid is greater than or equal to 15 g/kg. In a NTP report (1982), chosen as supporting study, groups of F344 rats were administered a single dose of 11 -aminoundecanoic acid (6810 -21500 mg/kg bw) by gavage and observed for 14 days. Deaths occurred only in females at the highest dose levels (14700 and 21500 mg/kg bw) and decrease in mean body weight was observed in males and females at these doses. Under the conditions of this test, the LD50 is above 14700 mg/kg bw. All together, these results showed that 11 -aminoundecanoic acid is of low acute toxicity to mammals.

Acute dermal toxicity:

One study is reported for this endpoint (IFREB, 1978). This study similar to OECD TG 402 has been selected as key study. Male and female Sprague-Dawley rats were tested for a single cutaneous application of 11 -aminoundecanoic acid at dose levels of 1000 and 2000 mg/kg bw for 24h. No death occurred and no anomaly in appearance and behaviour was recorded throughout the 14 -day observation period. Under the experimental conditions of this test, there was no toxic effect linked to the 11 -aminoundecanoic acid.

Conclusion:

In conclusion, the acute toxicity of 11-aminoundecanoic acid is negligible via oral and dermal route (oral LD50 in rats >14700 mg/kg, and dermal LD0 in rats > 2000 mg/kg).

Justification for classification or non-classification

Acute oral: not classified (LD50> 14700 mg/kg)

Acute dermal: not classified (LD0> 2000 mg/kg)

Based on these data, no classification for acute toxicity has to be applied for 11-aminoundecanoic acid according to EU Directive 67/584/EEC and EU regulation (EC) No 1272/2008 (CLP).