Registration Dossier

Administrative data

Description of key information

An acute oral toxicity tudy is available for a substance analogue. The resulting oral LD50 shows that the oral LD50 can reasonably be considered to be 3422 mg/kg bw.

An acute dermal toxicity study conducted with a member of the chemical category in accordance with OECD 402 and according to GLP principles was considered appropriate to determine the acute dermal toxicity of the substance. The acute dermal toxicity was determined to be above 2612 mg/kg in a limit test.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5.85 mL/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
95% CL:
>= 5.4 - <= 6.3
Remarks on result:
other: Aqueous solution with a solid content of approximately 50%
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 844.5 mg/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 50%
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 422 mg/kg bw
Based on:
other: expressed as solid content
Remarks on result:
other: Results expressed for the substance
Mortality:
One, three, seven and seven animals died in the group of rats receiving 5.0, 5.5, 6.25 and 6.5 mL/kg bw (aqueous solution), respectively
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

RESULTS: 

Group

Dose

(mL/kg b.w.)

(aqueous solution)

Mortality

Group mortality

(%)

1

5.0

1/10

10

2

5.5

3/10

30

3

6.25

7/10

70

4

6.5

7/10

70

Interpretation of results:
not classified
Conclusions:
In an acute oral toxicity study conducted equivalent to OECD 401, the LD50 was determined to be 5.85 mL/kg (aqueous solution), converted to be 6844 mg/kg (as the density is 1.17 g/mL). This would correspond to a LD50 of 3422 mg/kg for the substance. This result is read acros to Amphoacetates C8-C10.
Executive summary:

The test material was tested as an aqueous solution (ca. 50% solids) for acute oral toxicity in the rat. The test article was administered as a 1:1 dilution in water in a single oral dose at 5.0, 5.5, 6.25, and 6.5 mL/kg dose volumes to groups of 10 fasted rats. Examinations for mortality and clinical signs were performed daily for 7 days. One and 3 animals died in the groups administered 5.0 and 5.5 mL/kg, respectively. Seven animals died in the groups receiving 6.25 and 6.5 mL/kg of the test substance. Based on these results, the acute oral LD50 was calculated to be 5.85 mL/kg (aqueous solution), with 95% confidence limits of 5.4 - 6.3 mL/kg. With a density documented to be approximately 1.17, the LD50 is estimated to be 6844 mg/kg for the aqueous solution. This corresponds to a LD50 of 3422 mg/kg for the substance. This result is read acros to Amphoacetates C8-C10.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 422 mg/kg bw
Quality of whole database:
A reliable study on a substance analogue is available.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In Section 13 of the IUCLID dossier, a report is attached in which the category approach is reported according to ECHA Guidance for the implementation of REACH, Guidance on information requirements and chemical safety assessment, Chapter R.6 (reporting format for a chemical category).
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 236 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 612 mg/kg bw
Based on:
other: expressed as solid content
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: expressed as surfactant content
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal acute LD50 (rat) of Alkylamidoamine glycinate maj. C12-14 (amphoacetate; C8-C18 alkyl derivatives) was found to exceed 2612 mg/kg bw (expressed as solid content). This result is read across to C8-C10 Amphoacetates.
Executive summary:

An acute dermal toxicity study (limit test) was conducted with Alkylamidoamine glycinate maj. C12-14 (amphoacetate, C8-C18 alkyl derivatives) in accordance with OECD 402 and according to GLP principles. A total of 10 rats (5 males and 5 females) were occlusive exposed to 4.47 mL/kg of an aqueous solution of the substance for 24 hours. The dose level was based on the surfactant content of the substance. One female was found dead on day 2. The majority of surviving animals showed chromodacryorrhoea, laboured respiration, rales, gasping, salivation, piloerection and hypothermia between days 1 and 2. No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning autolysis was observed for the female that was found dead on day 2. Based on the results of this study the substance does not need to be classified for acute dermal toxicity in accordance with the CLP Regulation as the acute dermal toxicity of the substance was determined to be above 2612 mg/kg. This result is read across to C8 -C10 Amphoacetates.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 612 mg/kg bw
Quality of whole database:
One study is available (Klimisch score 1), conducted with a substance analogue.

Additional information

Acute toxicity oral:

The test material was tested as an aqueous solution (ca. 50% solids) for acute oral toxicity in the rat. The test article was administered as a 1:1 dilution in water in a single oral dose at 5.0, 5.5, 6.25, and 6.5 mL/kg dose volumes to groups of 10 fasted rats. Examinations for mortality and clinical signs were performed daily for 7 days. One and 3 animals died in the groups administered 5.0 and 5.5 mL/kg, respectively. Seven animals died in the groups receiving 6.25 and 6.5 mL/kg of the test substance. Based on these results, the acute oral LD50 was calculated to be 5.85 mL/kg (aqueous solution), with 95% confidence limits of 5.4 - 6.3 mL/kg. With a density documented to be approximately 1.17, the LD50 is estimated to be 6844 mg/kg for the aqueous solution. This corresponds to a LD50 of 3422 mg/kg for the substance. This result is read acros to Amphoacetates C8-C10.

Acute toxicity: dermal

An acute dermal toxicity study (limit test) was conducted with a related member of the chemical category (C8-C18 alkyl derivatives) in accordance with OECD 402 and according to GLP principles. A total of 10 rats (5 males and 5 females) were occlusive exposed to 4.47 mL/kg of an aqueous solution of the substance for 24 hours. The dose level was based on the surfactant content of the substance. One female was found dead onday 2.The majority of surviving animals showed chromodacryorrhoea, laboured respiration, rales, gasping, salivation, piloerection and hypothermia between days 1 and 2. No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning autolysis was observed for the female that was found dead on day 2. Based on the results of this study the acute dermal toxicity of the substance was determined to be above 2612 mg/kg.

The read-across from this member of the chemical category alkylamphoacetates to the registered substance for the acute dermal toxicity of the substance is considered scientifically justified based on the overall information available (see report for the category approach in IUCLID chapter 13).

Justification for classification or non-classification

Based on these experimental results and the 2017 CESIO recommendations for CAS 68608-64-0, the oral LD50 is considered to be higher than 5000 mg/kg. Therefore no classification according to CLP or UN-GHS criteria is warranted.

In accordance with the CLP Regulation the substance is not classified for dermal toxicity as the LD50 oral in rats determined to be more than 2612 mg/kg bw.