Registration Dossier
Registration Dossier
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EC number: 238-122-3 | CAS number: 14246-53-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- february 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: this study was performed in 1979 and it is not following GLP guidelines. Prior to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: none mentioned
- Deviations:
- not specified
- Principles of method if other than guideline:
- Subacute oral toxicity, 10 male and 10 female rats per group, treated for 10 days and further observed for 15 days
- GLP compliance:
- no
- Remarks:
- prior to GLP
- Test type:
- other: subacute oral toxicity
- Limit test:
- yes
Test material
- Reference substance name:
- N-(1-oxooctyl)glycine
- EC Number:
- 238-122-3
- EC Name:
- N-(1-oxooctyl)glycine
- Cas Number:
- 14246-53-8
- Molecular formula:
- C10H19NO3
- IUPAC Name:
- N-(1-oxooctyl)glycine
- Reference substance name:
- LIPACIDE C8G
- IUPAC Name:
- LIPACIDE C8G
- Details on test material:
- - Name of test material (as cited in study report): LIPACIDE C8G
- Substance type: Substance well identified
- Physical state: solid
- Lot/batch No.: CA77248
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: the farm of the OCINS, IFFA CREDO
- Weight at study initiation: 140 - 150g
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Gum Arabic at 5%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5% - Doses:
- 2500mg/kg/day
5000mg/kg/day
10000mg/kg/day - No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: twice per day
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
After 10 days of consecutive treatment, the product LIPACIDE C8G was found to have a subacute oral LD 50 greater than 10 g/kg- Clinical signs:
- other: The following symptoms were observed. 2.5 g/kg/day No abnormal symptoms have been observed. The deaths occurred between the 6th and 15th day after the beginning of the treatment. (3 of 20) 5 g/kg/day No abnormal symptoms have been observed. The dea
- Gross pathology:
- none
- Other findings:
- none
Any other information on results incl. tables
The product when administered orally had and LD50 greater than 10 g/kg after 10 administrations on consecutive days as a 5 % suspension in gum Arabic.
Mortality
Subacute oral toxicity in the rat
Dose (g/kg/day) (a) |
Mortality (b) of LD 50 After 10 days of treatment and 15 days observation Lipacide C8G (c) |
2.5 |
3/20 |
5 |
2/20 |
10 |
2/20 |
LD 50 g/kg |
Greater than 10 |
(a) Weight of principle active. (c) The product LIPACIDE C8G as a suspension in gum Arabic. |
|
Weight Change of the Animals Treated by the Product – Lipacide C8G
Subacute oral toxicity in the rat
Product dose g/kg/day |
Sex |
Average Weight ± Typical error After ‘n’ days from the start of treatment |
|||||||
n = 0 |
n = 4 |
n = 7 |
n = 11 |
n = 15 |
n = 18 |
n = 22 |
n = 25 |
||
Control (0) |
♂ |
140±21.5 |
162.6±19.3 |
197.5±21.3 |
215±23.5 |
243±20.7 |
268.4±23.2 |
289.6±23.2 |
301±23.8 |
Lipacide C8G (2.5) |
♂ |
160.5±7.6 t = 1.4 n.s. |
165.9±16 t = 0.197 n.s. |
184.4±22.8 t = 1.05 n.s. |
206.5±20.4 t = 0.71 n.s. |
240.8± 28.2 t = 1.45 n.s. |
297.8 ± 20.3 t = 0.97 n.s. |
297.8± 18.2 t = 0.67 n.s. |
313.8±19.8 t = 1.08 n.s. |
Lipacide C8G (5) |
♂ |
167± 10 t = 2.13 n.s. |
147.5± 20.7 t = 2.2 (a) |
155.8± 22.6 t = 3.36 (b) |
171.8± 22.8 t = 3.36 (b) |
186.2± 27 t = 4.04 (b) |
203.4± 29 t = 3.8 (b) |
232.5± 34.1 t = 3.19 (b) |
245.8± 36.2 t = 3.02 (a) |
Lipacide C8G (10) |
♂ |
166± 12.2 t = 1.86 n.s. |
145.8± 17.8 t = 17.8 (a) |
149.7± 25.2 t = 3.57 (b) |
163.8± 22.3 t = 3.94 (b) |
188± 30.2 t = 3.55 (b) |
206.3 t = 3.05 (a) |
235.6 ± 53.4 t = 2.07 n.s. |
247.7± 63.3 t = 1.78 n.s. |
Control (0) |
♀ |
159± 2.2 |
166.6± 4.2 |
186.6± 7.1 |
193.2± 7.7 |
200.2± 3.27 |
207.3± 9 |
217± 14 |
221± 5.5 |
Lipacide C8G (2.5) |
♀ |
159.5± 6.9 t = 0.15 n.s. |
159.4± 9.1 t = 1.65 n.s. |
158.4± 17 t = 3.5 (b) |
174±17.5 t = 2.31 (a) |
192.8 ± 19.6 t = 0.82 n.s. |
206±17.3 t = 0.15 n.s. |
215.1± 15.8 t = 0.21 n.s. |
214.4± 17.4 t = 0.81 n.s. |
Lipacide C8G (5) |
♀ |
158.3± 6.1 t = 0.23 n.s. |
144.5± 15.8 t = 3.00 (a) |
155.8± 11.3 t = 5.5 (b) |
169± 18 t = 2.84 (a) |
185.9± 17.4 t = 1.79 n.s. |
196.1±19.2 t = 1.6 n.s. |
204.2± 23.5 t =1.10 n.s. |
206± 26.1 t = 1.18 n.s. |
Lipacide C8G (10) |
♀ |
152.5± 4.3 t = 3.16 (a) |
140.2 ± 14.7 t = 3.86 (b) |
149.8± 14.2 t = 5.39 (c) |
155.6± 14.3 t = 5.43 (c) |
168.4± 29.3 t = 2.38 (c) |
182.4± 28.1 t = 2.15 n.s. |
191.4± 27.2 t = 1.95 n.s. |
193.8± 17.5 t = 2.15 n.s. |
(a) Difference statistically significant in comparison with the control group: p <0.05
(b)Difference statistically significant in comparison with the control group: p <0.01
(c)Difference statistically significant in comparison with the control group: p <0.001
Food Consumption during the study of the subacute oral toxicity in the rat
Product: Lipacide C8G
Product dose g/kg/day |
Sex |
Food consumption in g/rat/day after ‘n’ days following start of treatment |
||
n = 9 |
n = 10 |
n = 11 |
||
0 |
♂ |
20 |
19 |
23.4 |
2.5 |
♂ |
19.5 |
18.5 |
22.5 |
5.0 |
♂ |
16.1 |
16.5 |
19.5 |
10 |
♂ |
12.7 |
14.5 |
18.75 |
0 |
♀ |
16 |
14.6 |
17.4 |
2.5 |
♀ |
20.5 |
14.3 |
19.4 |
5 |
♀ |
16.3 |
15.6 |
16.5 |
10 |
♀ |
12.6 |
11.7 |
14.6 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The product when administered orally had and LD50 greater than 10 g/kg after 10 administrations on consecutive days as a 5 % suspension in gum Arabic
- Executive summary:
The product when administered orally had and LD50 greater than 10 g/kg after 10 administrations on consecutive days as a 5 % suspension in gum Arabic The product when administered orally had and LD50 greater than 10 g/kg after 10 administrations on consecutive days as a 5 % suspension in gum Arabic
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