Glycerides, mixed C8-10 and succinyl

Endpoint summary

Description of key information

Skin irritation: not irritating

Eye irritation: 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

The skin irritation potential of Glycerides, mixed C8-C10 and succinyl was investigated in a study conducted according to OECD guideline 404 (Dufour, 1992). The undiluted test material (0.5 mL) was applied to the intact skin of 3 male rabbits for an exposure period of 4 h under occlusive conditions. Skin effects were evaluated at 1, 24, 48 and 72 h after patch removal. No local irritating effects were observed at any reading time point and the study was therefore terminated 72 h after exposure. No further local or systemic effects were noted. The mean values for erythema and edema from gradings at 24, 48 and 72 h were both 0 in all 3 animals. Therefore, the substance was considered to be not irritating to the skin.

In an early study, the substance Glycerides, mixed C8-C10 and succinyl was tested for skin irritation according to the method described in F.D.A. (1959) Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (Consultox Laboratories Ltd., 1979). The test material was applied undiluted to the intact and abraded skin of 6 rabbits for a 24 h exposure under occlusive conditions. Dermal reactions were scored after patch removal and 72 h post-application (end of the study). On the intact skin, very slight erythema was seen at 24 h in 3/6 animals, being fully reversible at 72 h in one of them. Very slight edema was noted at 24 and 72 h in one animal. No skin reactions were observed in the remaining 3 animals. Assuming that the effects observed on the intact skin at 24 h persisted at 48 h (worst case assumption), the overall mean values for erythema from gradings at 24, 48 and 72 h of all 6 animals would be 0.5. The corresponding value for edema would be 0.2. The substance was considered to be not irritating to the skin.

Eye irritation

The eye irritation potential of Glycerides, mixed C8-C10 and succinyl was investigated following the method described in F.D.A. (1959) Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (Consultox Laboratories Ltd., 1979). The undiluted test material (0.1 mL) was placed into the conjunctival sac of one eye of 6 male rabbits each. The other eye remained untreated and served as control. Three of the treated eyes were washed 4 seconds after instillation and therefore not further considered herein. The eyes were examined and scored 1, 24, 48, 72 and 96 h and 7 days after application, when the study was terminated. Among the 3 rabbits whose treated eyes remained unwashed, one animal presented no ocular effects at all; in the second animal slight conjunctival redness was observed at the 1 h reading, being fully reversible at 24 h; the third animal showed well-defined conjunctival redness at 1 h, decreasing to slight at 24 and 48 h, and disappearing at 72 h. No chemosis and no effects in the cornea or iris were noted in any animal. The individual mean conjunctivae scores from gradings at 24, 48 and 72 h in the 3 animals were 0.0/0.0/0.7. The substance was therefore considered to be not irritating to the eyes.

Conclusions for irritation / corrosion

The substance Glycerides, mixed C8-C10 and succinyl has been tested for skin and eye irritation in vivo and the available studies show that the substance is not irritating to the skin and eyes.

Justification for selection of skin irritation / corrosion endpoint:

The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:

There is only one study available.

Justification for classification or non-classification

The available data on the skin and eye irritation potential of Glycerides, mixed C8-C10 and succinyl do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

There are no data available on respiratory irritation.