Nitrilotriacetic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

Trilon A

IUPAC Name:

Trilon A

Constituent 2

Reference substance name:

Trisodium nitrilotriacetate

EC Number:

225-768-6

EC Name:

Trisodium nitrilotriacetate

Cas Number:

5064-31-3

IUPAC Name:

trisodium 2,2',2''-nitrilotriacetate

Details on test material:

Trilon A 92, purity 92.4%

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

Age of the animals: Young adult animals
Body weight range at the beginning of the study: 347 - 399 g
Acclimatization period: 8 days before the beginning of the study in the laboratory for dermal toxicity.
The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70 %.
Illumination period: 12 h light and 12 h darkness
Stainless steel wire mesh cages with plastic-coated grating, floor area 40 cm x 51 cm, were used.
No . of animals per cage: 5
Identification of the animals: Ear tattoo
Type of diet : Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet) ad libitum
Water ad libitum (tap water; about 2 g of ascorbic acid per 10 1 water was added to the drinking water twice a week)

Study design: in vivo (non-LLNA)

Induction

Induction 1

Vehicle:

water

Induction 2

Concentration / amount:

The following concentrations for induction and the challenge were selected on the basis of the pretests:
1st, 2nd and 3rd induction: 50% in aqua bidest.
Challenge: test substance 50% in aqua bidest.

Challenge

Challenge 1

Vehicle:

water

Challenge 2

Concentration / amount:

The following concentrations for induction and the challenge were selected on the basis of the pretests:
1st, 2nd and 3rd induction: 50% in aqua bidest.
Challenge: test substance 50% in aqua bidest.

No. of animals per dose:

Number of animals per control group : 10
Number of animals of the test group : 20

Details on study design:

Form of application: percutaneous occlusive
Percutaneous application is simulating dermal contact with the compound also possible to occur under practical use conditions. Occlusive dressing has been recommended by the original publication / guideline to avoid evaporation and to guarantee maximum skin contact.
The study was performed on 20 guinea pigs in the test group and 10 animals in each of control groups 1 and 2.
The animals of the control groups were used to rule out a substance induced primary skin irritation.
A second control group (control group 2) has been intended for a potential rechallenge in case of borderline results at the challenge. Control group 1
cannot be used in this case due to a possible sensitization by the single application of the test substance at the challenge.

Positive control substance(s):

yes

Results and discussion

Any other information on results incl. tables

The 1st, 2nd and 3rd induction with 50% test substance preparations did not cause any signs of skin irritation in all test group animals. A challenge was performed 14 days after the last induction. The number of animals with skin findings after the challenge was as followed: control group 1 - 0/10, test group - 0/20.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Based on the results of this study it was concluded that Trilon A 92 does not have a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.