Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data were identified on EDDS acid.

In a GLP study conducted according to OECD Guideline 406 and EU method B.6, trisodium EDDS was assessed for its sensitisation potential when applied to the skin of albino guinea pigs (modified Buehler method). Groups of ten guinea pigs of each sex were exposed to a 50% solution of the test substance for 6 h under an occluded patch applied to the clipped shoulder region, followed by two further exposures at 7-day intervals. After a 2-week recovery period, the animals were exposed to a 50% challenge dose and observed for skin reactions for 48 h. Groups of five animals of each sex were used as negative controls, receiving only the challenge dose. There was no evidence of positive skin reactions either after the induction exposures or after the challenge dose in any of the animals. No deaths occurred during the study and no clinical signs of toxicity or effects on body weight gain were seen (Arcelin, 1993c).

In a GLP study conducted according to a protocol similar to OECD Guideline 406, trisodium EDDS was assessed for its ability to induce skin sensitisation in albino guinea pigs (modified Buehler method). Groups of ten animals of each sex were placed in Buehler restrainers and exposed to an induction dose of 0.5 g of neat trisodium EDDS in an occluded Hilltop chamber for 6 h. The induction process was repeated 7 and 14 d later. After a further 14 d the treated animals and an untreated control group (5/sex) received a challenge dose of 0.5 g for 6 h. The test sites were scored for erythema and edema 24 and 48 h after patch removal. in addition, the test sites were rechallenged 7 d later. One animal in the treatment group showed slight confluent erythema 24-h after challenge application; all other animals in this group as well as the control group showed no reaction or slight patchy erythema at 24 and 48 h post challenge. The positive controls developed moderate to severe erythema demonstrating the validity of the study. One animal in the treatment group died on day 20 (prior to the challenge phase) from undetermined causes; all other animals remained healthy and gained in body weight throughout the study (Merriman, 1995).

In a GLP study, trisodium EDDS was assessed for its skin sensitising potential in a human repeat insult patch test. During the induction phase, a 5% solution was applied to the skin of the upper arm of more than 100 individuals for 24 h under an occluded patch on alternate working days over a three-week period (9 applications). Between 12-20 days after the last induction exposure, a challenge dose of 5% was applied under an occluded patch to the same area and as a control to a similar site on the other arm. The test areas were examined at 48 and 96 h after application of the challenge dose. No evidence of either irritation during the induction stage or of sensitisation after the challenge application was observed in any of the 111 individuals who completed the study (Rybicki, 1993).

[Data on trisodium EDDS is considered relevant to use for understanding the sensitisation potential of EDDS acid, and is acceptable for using as read-across information.]


Migrated from Short description of key information:
No data were identified on EDDS acid.

In a GLP study conducted according to OECD Guideline 406 and EU Method B.6, the related material trisodium EDDS showed no sensitising potential to the clipped skin of guinea pigs after induction by three weekly exposures to 50% of the test material followed two weeks later by a 50% challenge dose (Arcelin, 1993c).

In a GLP study conducted according to a protocol similar to OECD Guideline 406, trisodium EDDS showed no sensitising potential when applied to the clipped skin of guinea pigs after induction by three weekly exposures to 100% (0.5 g) of the test material followed two and three weeks later by a 100% challenge dose (Merriman, 1995).

In a GLP study, trisodium EDDS showed no sensitising potential when 5% (in water) was applied to the skin of more than 100 volunteers in a human repeat insult patch test (Rybicki, 1993).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no data relating to respiratory sensitisation in humans or laboratory animals. However, due to their low vapour pressure and lack of skin sensitisation potential, it is unlikely that EDDS acid (or its trisodium salt) would cause such an effect.


Migrated from Short description of key information:
There are no data relating to respiratory sensitisation in humans or laboratory animals. However, due to their low vapour pressure and lack of skin sensitisation potential, it is unlikely that EDDS acid (or its trisodium salt) would cause such an effect.

Justification for classification or non-classification

According to EU CLP and DSD regulations, EDDS acid (and its trisodium salt) would not be classified as a skin or respiratory sensitiser on the basis of the infomation provided above.