Ammonium oleate

Endpoint summary

Description of key information

oral:
For an analogue substance a LD50 value of 47.3 mL/kg bw  (42097 mg/kg bw) was determined in rats after oral administration.
intravenous:
After intravenous application, a LD50 of approximately 267 mg/kg bw was determined for the analogue substance.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

For justification of read-across see section 13.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

47.3 mL/kg bw

Based on:

test mat.

95% CL:

> 40.9 - < 54.7

Remarks on result:

other: 47.3 mL/kg bw can be converted to 42097 mg/kg bw using the density of the test substance (0.89 g/cm^3 = densitiy of CAS 112- 80-1)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

42 097 mg/kg bw

Quality of whole database:

non-GLP study, equivalent or similar to OECD Guideline. Please refer to IUCLID section 13 for read across justification.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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

Oral:

An oral toxicity study with the analogue substance 9-octadecenoic acid (CAS: 112-80-1) was conducted on rats. The animals were fasted for 24 hours, afterwards the substance was administered by gavage. 5 rats each (including males and females) received one of the following doses: 4, 8, 16, 32, 40, 48, 64 mL/kg bw. The animals were observed daily for a period of 2 weeks. Deaths occurred from the 40 mL/kg bw dose group onwards: one animal of this group died on day 2, 3 rats of the 48 mL/kg dose group and all rats of the highest dose group died on day one. All dosage levels from 16 mL /kg bw and above had nasal hemorrhage, crustated ocular areas, oozed urine and appeared to be debilitated prior to death. On the basis of these results, the LD50 value of the analogue substance was determined to be 47.3 mL/kg bw (which correlates to 42097 mg/kg bw). The LD 0 was found to be 32 mL/kg bw and the LD 100 value was 64 mL/kg bw. The LD50 value was converted to 42097 mg/kg bw using the densitiy of the substance (0.89 g/cm3): 0.0473 L*0.89 g/0.001L= 42.097g = 42097 mg.

Intravenous:

In a publication an experiment is described in which 9-octadecenoic acid was administered to rats by intravenous injections to investigate the effects on the lungs. Therefore, adult male Fischer 344 rats were used. As injections of about 80 µL (356 mg/kg bw) of the analogue substance led to a high rate of mortality (compared to similar doses administered to larger animals in other studies) and because injecting of smaller amounts was not feasible, the doses were reduced by suspending the read across substance in saline-albumin solution in a ratio of 1:5. A volume of 250 µL of this suspension then was injected via the penile vein in anesthetized rats. They were sacrificed after different time intervals: 10 minutes, 30 minutes, 1 hour, 6 hours, 24 hours, 4 days, 12 days and 4 weeks. Control animals received 1 mg/dL albumin solution. As a result, histologic changes in the lungs (perivascular interstitial and intra-alveolar edema, vascular congestion, intravascular coagulation, intra-alveolar hemorrhage) were found within minutes after application. After 24 hours, an interstitial infiltrate of alveolar lining cells and macrophages was observed. Further development of the lesion was comparable to the respiratory distress syndrome. Chronic pulmonary inflammation or fibrosis was not found. The LD50 of the read across substance as a suspension in albumin was approximately 60 µL. The LD50 value 60 µL (given in the publication) was converted using the substance densitiy (0.89 g/cm3): 60 µL*0.89 g/1 mL=0.06 mL*0.89 g/mL=0.0534 g, weight rats: max. 200 g; 53.4 mg/0.2 kg = 267 mg/kg.

In another publication the effects of intravenous injections of an analogue substance on the lungs of dogs are examined. The substance was administered at two dose levels in a single injection (0.045 g/kg bw or 0.09 g/kg bw). Control animals received normal saline injections. Animals of the single-injection-groups were sacrificed after 1, 2, 4, 6 and 24 hours and 1, 2 and 4 weeks after injection. Additionally, 3 dogs of the 0.09 g/kg group were sacrificed at 3, 12 and 48 hours. As a result, mostly ventral and subpleural hemorrhagic lesions were observed in the early stage. Later yellow-tan patches were seen over the pleura. Lesions occurred mostly on the ventral sides of the lower lobes. Light microscopic examination revealed normal lung areas and damaged areas, these were more distinct in the higher dose group of the single injection-group. Large microcysts were seen in the peripheral portions of the lobe. After 1 week acute lesions had disappeared except for moderate edema. Fibrotic areas scattered over the lungs were found as well as thickened alveolar walls containing macrophages. These macrophages were less numerous after 2 weeks and 1 month, but the extent of fibrosis increased.

Justification for selection of acute toxicity – oral endpoint
only study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral toxicity 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 acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.