C12-18-(even numbered, C18 unsaturated)-alkylamines acetates

Endpoint summary

Description of key information

There are no human data on acute toxicity for the test item available. In animals, test results with this substance are available for the oral route of exposure indicating a LD50 above 2000 mg/kg body weight. With regard to the dermal route of exposure, results from analogous primary alkyl amines revealed a LD50 greater 2000 mg/kg body weight. Testing of the inhalation route is waived based on the physico-chemical characteristics. Additionally, the material is corrosive to skin and thus sufficient risk management measures are in place to minimize any exposure. 

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
males: mean = 205 g, SD = 7, xmin = 197, xmax = 213, n=5
females: mean = 198 g, SD = 5, xmin = 192, xmax = 204, n=5

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage):

MAXIMUM DOSE VOLUME APPLIED:
25 ml (20% solution) = 2000 mg/kg bw

Doses:

1

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes

Statistics:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: squatting posture, decreased spontaneous activity, coat bristling, irregular respiration

Gross pathology:

Gross pathology of rats at the end of the observation period revealed in two cases that the stomach and pankreas was adhered to the connective tissue, in other cases no remarkable macroscopic findings were observed.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The median lethal dose of the substance (LD50) was > 2000 mg per kg body weight. Based on the result of this study the substance is not subject for labelling and classification requirements according to regulatory requirements

Executive summary:

The acute oral toxicity of the substance was investigated in rats using suspensions in deionized water oil at a concentration of 20%. 5 male and 5 female SPF-Wistar rats each were administered the substance by single-dose gavage at dose level of 2000 mg/kg body weight and were observed for 14 days after administration. After application the animals showed the following unspecific clinical symptoms: squatting posture, decreased spontaneous activity, coat bristling, irregular respiration. Gross pathology of rats at the end of the observation period revealed in two cases that the stomach and pankreas was adhered to the connective tissue, in other cases no remarkable macroscopic findings were observerd. The median lethal dose (LD50) was calculated to be > 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Guideline study according to GLP available. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information valid, meets data requirements and is considered sufficient with regard to classification and labeling.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no human data on acute toxicity available for the registration substance. In animals, the test item C12 -18 -(even numbered, C18 -unsaturated)-alkylamines acetates was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied using suspensions in deionized water at a concentration of 20%. 5 male and 5 female SPF-Wistar rats each were administered the substance by single-dose gavage at dose level of 2000 mg/kg body weight and were observed for 14 days after administration. After application the animals showed the following unspecific clinical symptoms: squatting posture, decreased spontaneous activity, coat bristling, irregular respiration. Gross pathology of rats at the end of the observation period revealed in two cases that the stomach and pancreas was adhered to the connective tissue, in other cases no remarkable macroscopic findings were observerd. The median lethal dose (LD50) was calculated to be > 2000 mg/kg body weight observed over a period of 14 days and is thus in good agreement with data on acute systemic toxicity with corresponding primary alkylamines.

No data concerning acute dermal and/or inhalation toxicity is available for the registration substance. However, based on read-across from test data for acute dermal toxicity of the analogous compound C12 -18 -(even numbered) alkylamines, which revealed a LD50 greater 2000 mg/kg body weight, additional testing of C12 -18 -(even numbered)-alyklamine acetates is not considered necessary. Testing for acute inhalation toxicity is waived based on the absence of acute systemic toxicity with regard to the oral and dermal route of exposure as well as the conclusion that inhalation is no exposure route of concern due to the physico-chemical characteristics of the registration substance. In addition, the registration substance is corrosive to skin and thus risk managment measures are in place sufficient to minimize any exposure.

Justification for selection of acute toxicity – oral endpoint
Guideline study according to GLP

Justification for selection of acute toxicity – inhalation endpoint
Waiving for scientific and exposure based reasons. Acute systemic toxicity can be excluded for the oral and/or dermal route of exposure. Additionally, due to the physico-chemical characteristics, no significant potential concerning inhalation exposure exist. Due to skin corrosive properties, sufficient risk management measures in place to minimize exposure.

Justification for selection of acute toxicity – dermal endpoint
Waiving for scientific and exposure based reasons. The substance exhibited no acute systemic toxicity following the oral route of exposure. Due to skin corrosive properties of the test material, sufficient risk management measures in place to minimize any exposure. Acute systemic toxicity following dermal exposure is also not to be expected based on read-across to acute dermal toxicity data from analogous primary alkylamines data.

Justification for classification or non-classification

Based on the LD50 value of greater 2000 mg/kg body weight and in accordance with GHS-CLP requirements, the registration substance is not classified for acute oral toxicity. With regard to acute dermal toxicity, read-across to the close analogue compound C12 -18 -(even numbered)-alkylamines justify no classification of the registration substance concerning this endpoint.