11-(heptylamino)undecanoic acid

Endpoint summary

Description of key information

An acute oral toxicity study was performed. N-heptyl-amino-11-undecanoic acid (NHAU) was administered orally in 10 males and 10 females at 3 hours interval at 10 g/kg. No mortality or clinical signs was recorded, therfore the LD0 was higher than 10g/kg

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:

From September 1973 to December 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The study was performed before the implementation of the guideline

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

The Test item was dissolved in suspension in CMC 0,5%.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 Animals per cage , diet provided ad libitum with water

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The test item was adminitered by gavage twice at 3 hours interval at 5 g/kg in total 10g/kg per animals

Doses:

10 g/kg

No. of animals per sex per dose:

8 males and 8 females

Control animals:

no

Details on study design:

8 males and 8 females were administered the test item at 3 hours interval a dose level of 5 g/kg in 0,5 carboxymethylcellulose for each administration, in total 10g/kg was administered for each animal.

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 10 other: g/kg

Based on:

test mat.

Mortality:

no mortality was observed.

Clinical signs:

no clinical signs was observed.

Body weight:

animals were about 180g to 200 g of body weight

Gross pathology:

not examined

Other findings:

none

Interpretation of results:

GHS criteria not met

Conclusions:

The DL0 was higher than 10g/kg, acute toxicity of n-Hau is low.

Executive summary:

The test item was administered orally twice  in 8 males and 8 females at 3 hours interval at 10 g/kg in total. No mortality or clinical signs was recorded, therfore the LD0 was higher than 10g/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

> 10 000 mg/kg bw

Additional information

The test item was administered orally twice  in 8 males and 8 females at 3 hours interval at 10 g/kg in total. No mortality or clinical signs was recorded, therfore the LD0 was higher than 10g/kg

Justification for classification or non-classification

In the acute oral toxicity in Sprague-Dawley, the LD0 was higher than 10 000 mg/kg

N-Heptyl-11-aminoundecanoic acid did not met the CLP or GHS criteria for acute oral classification.