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Diss Factsheets

Administrative data

Description of key information

No sensitisation response was elicited in an in vivo M&K maximisation study (OECD 406 guideline) conducted with DTPA trisodium salt. The substance has low potential for skin sensitisation

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 June 2001-3 August 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study undertaken in non-EU jurisdiction
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
1) Animals used
Thirty-six white guinea pigs of Std:Hartley strain (body weight and age at receipt: 251 to 283 g, 4 weeks old) were purchased on June 14, 2001, from Japan SLC, Inc. (3371-8 Kotoh-cho, Hamamatsu-shi, Shizuoka Prefecture) and were acclimatized by 11-day preliminary breeding. Thirty animals which were healthy and, in particular, without abnormality in the skin were selected and used in the study.
2) Identification method
At receipt, the animal number at receipt was entered on the right ear using an oil-based black felt-tip pen and, at group allocation, the test animal number was entered on the left ear using an oil-based red felt-tip pen. In addition, the cages and racks were identified by labeling and the animals were housed in the corresponding places.
3) Environmental controlsThe animals were housed individually in stainless wirenet cages (185W x 260D x 175H mm) in small Animal Room 2 controlled at 22 ± 3°C, 55 ± 15% humidity, 10 or more ventilations/hour, and illumination time of 8 hours/day (09:00 to 17:00). The animal room and racks were cleaned and the floor was disinfected with NEO-CHLOR Clean (Shikoku Chemicals Corporation) every day. The cages and trays were exchanged once in 3 weeks and 3 times a week, respectively.
The animals were freely accessed to commercially available solid food RC4 (Oriental Yeast Co., Ltd.) and tap water at Chihayaakasaka-mura from polycarbonate drinking water bottles.

Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
A supplied
Day(s)/duration:
after 0 (intradermal) , and 6 (epicutaneous days
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% w/v
Day(s)/duration:
After 21d
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1% w/v
Day(s)/duration:
after 21d
Adequacy of challenge:
not specified
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.1% w/v
Day(s)/duration:
after 21 days
Adequacy of challenge:
not specified
No. of animals per dose:
Ten
Details on study design:
Method of administration in the test substance sensitization group
(1) On the study initiation date (Day 0), a 4 x 6 cm area in the dorsal neck of guinea pigs was clipped using an electric shaver and shaven using an electric razor. In the area of 2 x 4 cm, 3 rows of 2 symmetric sites in the left and right were marked.
(2) 0.05 mL each of 3 dosing solutions prepared previously was injected intradermally (primary induction exposure).
Row (i): 0.1 mL of a water-in-oil type emulsion of distilled water and Freund’s complete adjuvant (FCA) in 1:1
Row (ii): 0.1 mL of the test substance (stock solution)
Row (iii): 0.1 mL of an emulsion of the test substance (stock solution) and FCA.
(3) At 6 days after the study initiation, the dorsal neck was clipped and shaven again, and 0.5 g of vaseline containing 10 w/v% sodium lauryl sulfate (SLS) was applied on the skin of the same area for 24 hours without closure. The area was cleaned with 70% ethanol on the next day.
(4) At 7 days after the study initiation, 0.2 mL of the test substance (stock solution) was applied on the same area, covered with a filter paper 2 x 4 cm in area and with nonpermeable adhesive dressing 4 x 6 cm in area, and fixed with Dermicel Cloth Tape (Johnson& Johnson Medical Inc.) for 48 hours (secondary induction exposure).
(5) At 21 days after the study initiation, a 5 x 5 cm area of the flank was clipped and shaven, and 0.1 mL each of 10, 1 and 0.1 w/v% test substance solutions were applied, covered with adhesive patches 2.5 cm in diameter for a patch test, and fixed with Dermicel for 24 hours (challenge exposure). In case of the positive control substance, one concentration of 0.1 w/v% DNCB solution was applied in the same manner as in the test substance treated group.

Challenge controls:
10 animals
Positive control substance(s):
yes
Remarks:
DNCB (2,4-dinitrochlorobenzene) in olive oil at 0.1% w/v. 5 test plus 5 control animals
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%, 1% and 0.1% w/v (irritant controls)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: No irritation observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%, 1% and 0.1% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%, 1% and 0.1% w/v (irritant controls)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: No irritation observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%.1% and 0.1% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% w/v (irritant controls)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
other: no skin irritation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
.1% w/v
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% w/v (irritant controls)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
other: No skin irritiaon
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% w/v
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation

No abnormal findings in general condition of the animals and and no differences in bodyweight indicative of an effect of the test substance.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not elicit skin sensitisation in guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

DTPA trisodium salt is considered not to meet the CLP criteria for classification for skin sensitisation.