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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted prior to the validation of the LLNA method and the finalisation of the OECD testing guideline (429).
Species:
guinea pig
Strain:
other: DHPW
Sex:
male
Details on test animals and environmental conditions:
animal number = 20
contol animal number = 10
TEST ANIMALS
- Source: Winkelmann, Borchen, Kreis Paderborn, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 355 g mean (304 - 391 g)
- Housing: Makrolon cages type IV, 5 animals/cage
- Diet: Altromin3022 ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): ca.50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours
Route:
other: intradermal and topical
Vehicle:
propylene glycol
Concentration / amount:
induction: 5 % and 25 %
challenge: 12 %
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
induction: 5 % and 25 %
challenge: 12 %
No. of animals per dose:
10
Details on study design:
first induction intradermal,
second induction topical one week later.
Challenge three weeks later.
Positive control substance(s):
yes
Remarks:
formaldehyde
Positive control results:
weak positive response, 1/10 animals at the 24 hour observation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 8.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In this study there is no evidence that 1H-Benzotriazole is a skin sensitizer.
Executive summary:

For the source chemicals Benzotriazole and Tolyltriazole well-conducted tests according to OECD TG 406 are available showing no skin sensitizing potential. This means that a similar result for Sodium Benzotriazolate can be anticipated.

  Even though it is expected that Sodium Benzotriazolate will also not be sensitising to the skin, in any case the substance is classified as corrosive to the skin and anin vivoskin sensitisation study does not need to be conducted

Sodium Benzotriazolate is not skin sensitizing. A hazard characterization for the dermal route can be based on this information.

Classification and labeling are not needed for this endpoint.

A risk characterization will be performed because the substance is classified for oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The analogue Benzotriazole is not skin sensitising, therefore Sodium Benzotriazolate is not skin sensitising.

Justification for selection of skin sensitisation endpoint:
The substance is skin corrosive and has not to be tested according to Annex VII, EC (No) 1907/2006.
The study of the analogue Benzotriazle is selected as the analogue is most similar to the substance.
This study has been provided for information purposes, noting that the actual test substance has been determined to be corrosive.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The substance is not skin-sensitising. No information on respiratory sensitisation is available.

The vapour pressure lead to the conclusion, that no inhalable fraction is present. Together with the non-skin-sensitising property, it can be assumed that the substance is not a respiratory sensitiser. (According to REACH technical guidance document: scheme of R7A, Fig 7.3-2)

Justification for classification or non-classification

The information on sensitation are conclusive but not sufficient for a classification according Regulation (EC) No. 1272/2008.