Alcohols, C16-18, reaction products with D-glucose

Endpoint summary

Description of key information

Skin irritation in vitro (OECD 431 and 439): not irritating
Skin irritation in vivo (OECD 404): not irritating
Eye irritation in vitro (OECD 437): not irritating
Eye irritation in vivo (OECD 405): not irritating

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:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

One in vivo study in rabbits according to OCED guideline 404 is available investigating the skin irritating potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) (Henkel, 1993). The undiluted test material (30% C16/C18-APG and 70% C16/C18 fatty alcohols) induced slight erythema in 2/3 animals, which were not fully reversible in one animal during the 21-day observation period. Slight edema was only observed in 1/3 animals and fully reversible within the study period. Based on these results, the reaction mass of Poly-D-Glucosides, C16 and Poly-D-Glucosides, C18 and C16/18 fatty alcohol may not be considered to be a skin irritant up to the tested concentration of 30% a.i..

Furthermore, two GLP-conform in vitro studies with the test substance to be registered (50% C16/C18-APG and 50% C16/C18 fatty alcohols) were performed according to OECD guidelines 431 (skin corrosion) and 439 (skin irritation) using a human skin model (BASF, 2012). For the assessment of skin corrosion, the undiluted test substance was applied to the intact reconstructed human epidermis under open conditions and cell viability was assessed after exposure periods of 3 and 60 min. Skin irritation was investigated after treatment of the tissue for 1 h followed by a 42-h post-treatment exposure period. In none of the treated tissues, significant reduction in cell viability was observed compared to control tissues after the respective exposure periods. Thus, the test substance was neither considered to be irritating nor corrosive to human skin.

Together with the negative results obtained in the in vivo skin irritation study with the test substance at a composition of 30% C16/C18-APG and 70% C16/C18 fatty alcohols, there is sufficient weight of evidence to show that the substance to be registered (50% C16/C18-APG and 50% C16/C18 fatty alcohols) does not have a skin irritating potential.

Eye irritation

One in vivo study is available on the eye irritation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) (Henkel, 1993). In this GLP-study performed according to OECD guideline 405, the undiluted test material (30% C16/C18-APG and 70% C16/C18 fatty alcohols) was placed into one respective eye of 3 rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Test substance instillation into the rabbit eye did not induce any effects, except for one animal which showed slight effects on conjunctivae that were fully reversible within 72 h. Based on these results, the reaction mass of Poly-D-Glucosides, C16 and Poly-D-Glucosides, C18 and C16/18 fatty alcohol at the indicated percentage of components may not be considered as eye irritant up to the tested concentration of 30% a.i..

An in vitro eye irritation study (HET-CAM test) with the undiluted reaction mass of Poly-D-Glucosides, C16 and Poly-D-Glucosides, C18 and C16/18 fatty alcohol (30% C16/C18-APG and 70% C16/C18 fatty alcohols) showed negative results on lysis or coagulation (Henkel, 1993). Only the CAM of one egg showed slight haemorrhage after exposure to the test substance for 5 min. Negative in-vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant (Category 2/R36). However, together with respective in vivo data on the test substance, it may be concluded that the substance is not irritating to the eye up to the tested concentration of 30% a.i..

Furthermore, three in vitro studies are available, which provide further evidence for the non-irritating potential of the test substance to be registered (50% C16/C18-APG and 50% C16/C18 fatty alcohols). In the first study, the Bovine Corneal Opacity and Permeability (BCOP) test was used to identify the potential for corrosivity and severe irritation (BASF, 2012). According to OECD guideline 437, the test substance at 10% solution in deionised water was applied to the epithelial surface of the isolated cornea of cattles for 10 min, followed by a 2-h post-exposure incubation period. After exposure, no changes in opacity and permeability were observed in corneas compared to control. Based on the measurements for opacity and permeability, an In Vitro Irritancy Score (IVIS) ≤ 55 was calculated after treatment with the test substance. Thus, no risk for serious damage to the eyes was identified (BASF, 2012). A subsequent BCOP test according to a modified surfactant protocol, which is based on the principles of OECD guideline 437, confirmed that the test substance at 10% solution in deionised water did not cause serious eye damage after the treatment of the epithelial surface of isolated corneas for a period of 1 h, followed by an 1-h post-exposure incubation period (BASF, 2013).

A further in vitro study was designed to predict the eye irritation potential of the test substance by using the human cornea model EpiOcularTM, which comprises a three-dimensional model of non-keratinised human epidermis (BASF, 2012). The undiluted test substance was applied to the surface of the EpiOcularTM tissue for 90 min, and cell viability was measured after an 18-h post-incubation period using the MTT assay. No reduction in cell viability of the treated tissue was observed compared to the control tissue. Thus, the test substance to be registered was not considered to have an eye irritation potential.

Based on a weight of evidence from all available studies and to avoid further animal testing, the test substance to be registered (50% C16/C18-APG and 50% C16/C18 fatty alcohols) is not considered to cause eye irritation.

 

Respiratory tract

This information is not available and not mandatory according to Regulation (EC) No. 1907/2006.

Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is based on the weight of evidence from all available studies.

Justification for selection of eye irritation endpoint:
Hazard assessment is based on the weight of evidence from all available studies.

Justification for classification or non-classification

The available data on the skin and eye irritation of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.