Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Endpoint summary

Description of key information

Skin:
- Skin irritation, Rabbit, 4h, OECD 404, AS 50%: very slight erythema score in 1 animals (0.33/4) other animals without signs, fully reversible within 48h (Henkel, BASF PCN, 1997)
Eye: 
- Eye irritation, Rabbit, OECD 405, AS 50%: mild to strong signs (cornea opacity 1.7, iris lesion 0.5, redness of conjunctiva 2.3 and chemosis 2). Not fully reversible within 21 days. (Henkel, BASF PCN, 1990)
- Eye irritation, Rabbit, OECD 405, AS 50%: no to severe signs (cornea opacity 0.1, iris lesion 0, redness of conjunctiva 1.9 and chemosis 1.2). Fully reversible within 7 days. (Henkel, BASF PCN, 1997)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

There are valid in vivo study data available assessing the irritating potential of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia.

 

Skin irritation:

OECD guideline conform studies:

A study of the skin irritant effect was performed with Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia tech. (50%) (internal Code: SAT 970396) in full compliance with the following guidelines: OECD No 404 (1992); EEC 92/69 - Annex V/B5 (1992) and under OECD principles of Good Laboratory Practice (1981) (Henkel, BASF PCN, 1997).

Therefore 3 New Zealand white rabbits where exposed for 4h to 0.5ml undiluted test material (DHW 80, AS 50%). Dermal irritation/corrosion as a result of reversible/irreversible inflammatory changes in the skin following the application of the test substance to one flank of the shaved back skin of the rabbits were examined. The untreated area of each animal serves as control.

The contact time under semi-occlusive conditions was four hours. the 24/48/72 hours mean scores were 0.1 (0.33, 0.00, 0.00) for erythema and 0.00 (0.00, 0.00, 0.00) for oedema. All skin reactions disappeared within 48 hours after application.

In result the substance was rated as not irritating to skin.

Key study assignment skin irritation:

As there is only one relevant and reliable study available assessing the skin irritation of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia and no further results are available, this study is included as key study.

 

Assessment skin irritation:

All available information is taken into account to assess the skin irritating potential of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia. As only a very slight dermal reaction was observed in a OECD conform study with DHW 80 (50%) the substance is assumed to be not irritating to skin.

 

Eye irritation:

OECD guideline conform studies:

 The test substance was tested for acute irritation effects on eyes of three rabbits (Kleinrussen, Chbb:HM) with a single dose of 0.1 g per conjunctival sac and a duration of exposure of 24 hours. [Method: Off. J. Europ. Commun. L251, 27, 109 -112 (1984) and OECD-Guidelines for Testing of Chemicals, No. 405] (Henkel, BASF PCN), 1990. Mild up to strong erythema and edema were observed (redness of conjunctiva 2.3 and chemosis 2). Weak up to moderate opacity was observed on the cornea (mean score 1.7). Additionally, mild symptoms on the iris were observed (mean score 0.5). At two animals all relevant symptoms disappeared totally within 14 days, at one animal the symptoms did not disappear within 21 days. According to the test conditions the test substance has classified to be "strongly irritating" to mucous membranes.

In a second OECD 405 compliant study the eye irritation/corrosion of a test substance was observed. Therefore the test substance was instilled into one eye each of at least three rabbits. The untreated eyes serve as control. The study of the eye irritant effect was performed with Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia, tech. (internal Code: SAT 970396) in full compliance with the following guidelines: OECD No 405 (1987), EEC 92/69 - Annex V/B5 (1992), OECD Principles of Good Laboratory Practice (1981)

The substance (undiluted - 0.1 g, AS 50%) was instilled once into the eyes of 3 female albino rabbits, strain russian, for a 24 hours contact. The eyes were scored 24, 48 and 72 hours as well as 7 days after application. The following mean values for each animal, based on the results from the 24, 48 and 72 hour readings, were calculated.

Animal 1168: Opacity 0.3, Iris lesion 0, chemosis 1.3, erythema 2.0

Animal 1181: Opacity 0.0, Iris lesion 0, chemosis 1.3, erythema 1.7

Animal 1182: Opacity 0.3, Iris lesion 0, chemosis 1.0, erythema 2.0

After 7 days none of the animals showed eye reactions due to application of the test article.

Key study assignment skin irritation:

There are two relevant studies available assessing the eye irritation of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia. Both studies are conducted according to GLP and OECD guidelines. Therefore both are reliable and useful. As the study from Henkel (Henkel, BASF PCN, 1990) shows the most detrimental results, therefore this study is used as key study.

 

Assessment eye irritation:

All available information is taken into account to assess the eye irritating potential of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia.

All available studies were conducted according to suitable guidelines. The information available points to a moderate to severe eye effect. One of the available studies (which is therefore assumed as key study) shows irreversible effects on the iris. This severity could be not confirmed in another. But nevertheless as both tests were not conducted with 100% As the registrant believes in a worst case approach that severe and maybe irreversible effects are possible also more likely for 100% AS. Therefore the substance should be regarded as severely irritating to eye GHS cat. 1. 

Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin:

Based on the available information from skin irritation study were only negligible irritation was observed, the substance has not be classified according to EU, UN-GHS (EC 1272/2008 ) or DSD (67/548/EEC).

Labelling for skin irritation:

GHS: no classification

DSD: no classification

Eye:

Clear eye irritating effects were observed in two relevant and reliable eye irritation studies. The scores and reversibility seen in one of thes studies led to a classification as an severely irritating to eye (cat. 1) due to criteria of classification EC 1272/2008 and Xi R-41 according to EU-criteria (67/548/EEC). This classification is based on the fact that in one study 1 animal had still iris reaction after 21 days.

Labelling for eye irritation:

GHS: severely irritating to eye (cat. 1)

DSD: Xi R-41