Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
28 June to 6 August 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study using a modified version of the original Draize human sensitisation test, read-across

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Human repeat insult patch test in which individuals received nine applications of the related material trisodium EDDS on alternate working days over a three-week period and were challenged with the test substance 12-20 days after the last induction application.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trisodium EDDS (under code)
- Substance type: technical product
- Physical state: clear liquid
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: 1 January 1994
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects exposed: 111 finished the study (125 recruited)
- Sex: 74 females, 37 males
- Age: no specific data available, but minimum age based on applicable local laws and no more than 20% over the age of 65
- Race: no data available
- Demographic information: no data available
Clinical history:
- History of allergy or casuistics for study subject or populations: no data available
- Symptoms, onset and progress of the disease: no data available
- Exposure history: no data available
- Aggravating factors both in home and workplace: no data available
- Family history: no data available
- Medical history (for respiratory hypersensitivity): no data available
- Any other allergic or airway disorders: no data available
- Smoking history: no data available
Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: no data available
- Vehicle / solvent: water
- Concentrations: 5%
- Volume applied: no data available
- Testing/scoring schedule: induction: 20 days (nine 24 h exposure periods (on Mondays, Wednesdays and Fridays)); challenge: 1 exposure 12 to 20 days after last induction application; scoring: 48 and 96 h after challenge application
- Removal of test substance: subjects permitted to "cleanse in a normal manner" patch site after patch removal

EXAMINATIONS
- Grading/Scoring system: no data available
- Statistical analysis: not applicable

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no clinical signs observed in any tested individual

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 112 (at 48 h); 111 (at 96 h)
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

No skin reations were evident after the induction or challenge applications and no adverse events were reported

Applicant's summary and conclusion

Conclusions:
In a GLP study, the closely-related material 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.
Executive summary:

In a GLP study, the closely-related material 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.

In conclusion, trisodium EDDS showed no sensitising potential when 5% was applied to the skin of more than 100 volunteers in a human repeat insult patch test.

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