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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Read-across: GPMT; GLP; EU Method B.6 (Skin Sensitization); 5/10 female guinea pigs in control/test group, respectively; 7.5% (intradermal) and 70% (topical) for induction and 35% and 70% for challenge phase; no animal of the test group showed positive reactions; test substance is not a skin sensitizer

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
70 and 35%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
70 and 35%
No. with + reactions:
0
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
70 and 35%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 and 50%
No. with + reactions:
10
Total no. in group:
10
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Read across justification

The test item was not tested for its allergenic potential. It is acceptable to derive the information on sensitization from experimental data of a structural analogue (di-ammonium salt) since both are salts with similar structures. In addition, the lower molecular weight of the analogue gives a safety margin (a detailed read across justification is given in CSR, Annex I).

Procedure and results

To evaluate the allergic potential of the substance, a skin maximisation test in guinea-pig was perfomed (Ciba 1994b). Ten test and five control guinea-pigs were used in this study. For induction of animals, three pairs of intradermal injection were made. 6 days later, topical induction in the same area was performed after treatment with sodium lauryl sulphate in petrolatum. Control and test animals were challenged topically two weeks after the topical induction application using the test substance, 70 and 35% w/v in distilled water.

No skin reactions or signs of toxicity were recorded. There were no dermal reactions, other than staining of the dose site, seen in any of the test animals.

Discussion

The test substance did not induce any dermal reactions in test animals unless yellow staining of the application site. Thus, the test substance is considered to be as a non-sensitizer.


Migrated from Short description of key information:
To evaluate the allergic potential of the test substance, a skin maximisation test (EU B.6, GLP) in ten test and five control guinea-pig was perfomed with a structural analogue (di-ammonium salt). The substance did not induce any dermal reactions in test animals unless yellow staining of the application site. Thus, the test substance is considered to be as non-sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Commission Regulation (EU) 2018/1480 of Oct 4 2018.