Ammonium oleate

Endpoint summary

Description of key information

skin:
The structural analogue (9-octadecenoic acid) was not irritating to skin.
eye:
The structural analogue (9-octadecenoic acid) was not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48 h

Score:

0.04

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48 h

Score:

0.04

Max. score:

4

Reversibility:

fully reversible within: 48h

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

>= 0 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7d

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

>= 0.42 - <= 2.1

Max. score:

3

Reversibility:

fully reversible within: 7d

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

>= 0 - <= 1.62

Max. score:

4

Reversibility:

fully reversible within: 7d

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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

Skin irritation

In a skin irritation study the read across substance 9-octadecenoic acid (CAS: 112-80-1) was applied to the skin of 6 rabbits. Therefore, four test sites, approximately 10 cm apart, were prepared on the back of each animal. The hair was clipped, two of the test sites were abraded by making four epidermal incisions. Gauze patches (1.5 x 1.5 inch) were secured to the test areas by adhesive tape. 0.5 mL of the read across substance were introduced beneath the patch. The rabbits’ trunks were then wrapped in plastic trunk bands. Following the initial reading after an exposure time of 4 h, the test sites were washed. Readings were again made at 24 h and 48 h after application. The primary irritation index is calculated by adding the values for erythema or eschar formation, and edema at 4, 24 and 48 hours on intact and abraded skin (12 values) and dividing by six to obtain an individual score on each rabbit. As a result, the primary irritation index was 0.4. The mean erythema score (time 4 h /24 h /48 h) was 0.4 and the mean edema score was 0. No edema were found at any time, and erythema were reversible within 48 hours.

Eye irritation

A publication is available in which an experiment conducted on several substances that were known to cause borderline results or no irritation to eyes is described. The purpose of this experiment was to compare results of different laboratories carrying out eye irritation tests according to the Draize procedure on the same substances. Among these substances was the read across substance 9-octadecenoic acid potassium salt (CAS 143-18-0). Each substance was applied to 6 albino rabbits. The animals were observed at 24, 48 and 72 hours after application and on day 7. As a result, after 24 hours 5 out of 12 collaborating laboratories found signs of irritancy in the rabbits’ eyes caused by the analogue substance and 5 laboratories assessed borderline findings. Two collaborators did not find signs indicating eye irritation. After 48 hours signs indicating irritation were evaluated by one out of 12 collaborators and 2 collaborators had borderline findings. 9 collaborators evaluated the substance as non-irritating-. After 72 hours, the total number of animals showing any signs of eye irritation had decreased and still 9 collaborators evaluated the substance as non-irritant, 3 as borderline substance. On day 7 all tested animals were assessed symptom free. After 24 hours the mean scores for each six rabbits were between 0 and 2.0 (range 0) for corneal opacity, 0 - 0.65 for iritis, 0.42 - 2.1 for conjunctival redness and 0 - 1.62 for chemosis. Mean scores after 48 and 72 hours are not given in the publication. However, considering that the number of animals exhibiting signs of irritancy decreased during the observation period and even if assumed that the scores given for each finding stayed the same after 48 and 72 hours, the mean scores are will not increase for any symptom. The critical score for classification is therefore the mean cornea score of 2.0.

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 skin or eye irritation 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 skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.