Ammonium oleate

Carcinogenicity

Description of key information

No carcinogenic properties of the read across substance 9-octadecenoic acid were found.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

For justification of read-across see section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 451 (Carcinogenicity Studies)

GLP compliance:

not specified

Dose descriptor:

NOAEL

Remarks:

carcinogenicity

Effect level:

5 mg/L drinking water

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LOEL

Remarks:

systemic toxicity

Effect level:

5 mg/L drinking water

Based on:

test mat.

Sex:

male

Basis for effect level:

organ weights and organ / body weight ratios

Dose descriptor:

LOEL

Remarks:

systemic toxicity

Effect level:

5 mg/L drinking water

Based on:

test mat.

Sex:

female

Basis for effect level:

organ weights and organ / body weight ratios

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

chronic

Species:

rat

Quality of whole database:

Reliable and well documented publication

Carcinogenicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for carcinogenicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for carcinogenicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.

Additional information

No adequate animal data are available and no epidemiological studies investigating the carcinogenicity of the test substance were identified. However, data from a structural analogue (read across substance) are available.

 

A publication (Hiasa, Y. 1984) is available in which a 108 weeks carcinogenicity study conducted with the analogue substance 9-octadecenoic acid (CAS 11-80-1) on male and female F344 rats is described. 150 male and female rats each were allocated to three dose groups.The control group received distilled drinking water, whereas the other two dose groups received 2.5 and 5 % of the read across substance administered via the drinking water (distilled water) for a duration of 108 weeks. The water consumption was determined twice a week, body weights were recorded every 2 or 4 weeks. At the end of the study, blood samples and urine samples were taken from 20 rats of each dosage group (10 males and 10 females). All surviving animals were killed and an autopsy was conducted on these animals as well as on those that were killed or found dead during the study, where possible. The following organs were examined for tumors and other lesions: brain, spinal cord, salivary, pituitary and thyroid (including parathyroid) glands, thymus, lungs (including the trachea), heart, oral cavity and tongue, oesophagus, stomach, duodenum. jejunum, ileum, caecum, colon, rectum, liver, pancreas, spleen, adrenal glands, lymph nodes, skin, subcutis, preputial/clitoral gland, ear duct, eyes, Harderian gIands, musculature, sternum, femur and nasal cavity. These organs and tissues and the found tumors were fixed and sectioned and afterwards stained with haematoxylin and eosin. As an outcome of these examinations, neither blood or urine analysis results nor tumour incidences differed significantly between the control and the test groups. An effect according organ weights was observed: In the 5 % dosage group, the mean liver weights of the male animals and the mean heart, pancreas and adrenals weights of the females were significantly lower than in the control group, and the thymus weight in the females was higher. From this publication it might be concluded that the LOEL concerning organ weights and the NOAEL for carcinogenicity for both male and females is 5 % in the drinking water /day.

In another publication (Clement Ip 1997) the results of several studies are summarized. As a conclusion on consuming an analogue substance (CAS 112 -80 -1) it is noted that there was no carcinogenic effect observed.