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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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)

Inductionopen allclose all
Vehicle:
water
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.
Challengeopen allclose all
Vehicle:
water
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.