Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

Endpoint summary

Description of key information

The test substance was not irritating to the skin or to the eye. In human workers, isolated cases of respiratory irritation have been observed in the past.

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:

adverse effect observed (irritating)

Additional information

Skin irritation

In a Draize Test 3 male and 3 female rabbits were treated with a gauze patch, soaked with the test substance (0.5 g; Ciba-Geigy, 1974). The animals were treated on intact and scarified skin for 24 h under occlusive conditions. The skin was evaluated 24 h and 72 h after removal of the test substance, no scores were recorded for the 48 h time point. All scores for the intact skin were zero for edema and erythema in all animals at any recorded time point. A mild erythema was observed in 4/6 animals at the 24 hour time point when tested on scarified skin (average score = 0.67), reversible within 72 hours. Based on the data obtained for intact skin, average irritation scores for edema and erythema of 0.0 were calculated for all animals. Findings on scarified skin are not relevant for assessment of irritation potential based on current regulations, however even for scarified skin the observed skin reactions are far below the level of regulatory threshold. Since all scores for intact skin were zero, the missing 48 h time point is not considered to affect the assessment of the results negatively. Thus, based on this data, the test substance is considered to be not irritating to the skin.

 

Eye irritation

In a Draize Test, 0.1 g of the test substance was instilled into the conjunctival sac of the left eye of 3 male and 3 female animals with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. No ocular reactions were observed after 24, 48, 72 h and after 4 and 7 days in both rinsed and un-rinsed eyes, all scores recorded were zero. Thus, the test substance is considered as not irritating to the eye.

 

Respiratory irritation

In animal studies, no indication for an irritation potential was evident for the test article. However, isolated cases of respiratory irritation have been observed in highly exposed workers. It is unknown to what concentrations of test substance these workers have been exposed. It is further unknown, whether these reactions were due to an irritating potential of the substance or due to extreme amounts of material being inhaled. Nevertheless, following the worst case principle, the substance is considered to be irritating to the respiratory system and requires classification with H335: may cause respiratory irritation.

Justification for selection of skin irritation / corrosion endpoint:
acceptable for assessment

Justification for selection of eye irritation endpoint:
acceptable for assessment

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

- Based on the observations in human workers, the substance is classified with Xi; R37 Irritating to respiratory system.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

- Based on the observations in human workers, the substance is classified with H335: May cause respiratory irritation.