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EC number: 239-269-6 | CAS number: 15217-42-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
