Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitizing potential of Dusantox L was evaluated with the guinea pig maximalization test by GLP and OECD 406 method.

Maximum concentration not causing irritating effects in preliminary test: 20 %

Signs of irritation during induction:
Test of primary irritation with different concentration of the test sample was realised. The fixation time was 24
hours. One hour after removing bandage the sign of irritation was observed. The highest concentration not
giving rise to irritating effects  applied epicutaneously was 20% sample in olive oil.

The signs of irritation observation during induction have not been executed.

Evidence of sensitisation of each challenge concentration:
1st Challenge 24 hour:
In 48 hours after application seven animals had the positive skin reactions: two of the animals had the middle
repletion and the mild oedema, five of the animals had the mild or the dappled repletion and the mild or the very
In 72 hours after application the reaction was held over all the previous reagents, the reaction was expressed as the
repletion, the oedema and the separating of skin surface coats. For the animals numbered 28 and 30 the reaction was
held over the next 24 hours as the result of the allergic dermatitis.
Other observations:
The sensitivity and reliability control results of the test:
Applied substance - Benzocain (CAS No.94-09-7)
Intradermal induction exposition: 5% olive oil.
Epicutan exposition: 25% concentration in vaseline alba.
Challange concentration: 5% concentration in vaseline alba.
Test results : 60% positive dermal reaction. The test reliability was confirmed.

Seven of the animals from the group of 20 experimental animals had the positive skin changes, it is 35 % of the
positive skin reactions.
The substance is the middle strong allergen by this test.
The significant differences was not detected in enlarge and evolution between test group and negative control group.
Intoxication side effect was not observed.

Migrated from Short description of key information:
The skin sensitizing potential of Dusantox L was evaluated with the guinea pig maximalization test by GLP and OECD 406 method. The substance is the middle strong allergen by this test.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available.

Justification for classification or non-classification

The test substance is classified as skin sensitizer according to the classification criteria 67/548/EEC and regulation 1272/2008(GHS, CLP).