Registration Dossier
Registration Dossier
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EC number: 239-269-6 | CAS number: 15217-42-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Sodium Benzotriazolate is expected to be skin corrosive because the analogue Sodium Tolyltriazolate has shown skin corrosive properties in a well performed study (Klimisch score 1). The source chemical Sodium Tolyltriazolate is sufficiently similar to read-across towards Sodium Benzotriazolate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 4(or 5)-methyl-1H-benzotriazolide
- EC Number:
- 265-004-9
- EC Name:
- Sodium 4(or 5)-methyl-1H-benzotriazolide
- Cas Number:
- 64665-57-2
- Molecular formula:
- C7H7N3.Na
- IUPAC Name:
- sodium 4-methylbenzotriazol-1-ide
- Test material form:
- other: solution
- Details on test material:
- - Name of test material (as cited in study report): Preventol CI 7-50
- Molecular formula (if other than submission substance): C7H6N3Na
- Molecular weight (if other than submission substance): 155.13 g/mol
- Smiles notation (if other than submission substance): [Na+].CC1=C2N=N[N-]C2=CC=C1; [Na+].CC1=CC=C2[N-]N=NC2=C1
- InChl (if other than submission substance): InChI=1S/C7H6N3.Na/c1-5-2-3-6-7(4-5)9-10-8-6;/h2-4H,1H3;/q-1;+1; InChI=1S/C7H6N3.Na/c1-5-3-2-4-6-7(5)9-10-8-6;/h2-4H,1H3;/q-1;+1
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: solved
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd. Huntingdon, UK
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individual cages
- Diet: Ssniff K 4 ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 * 2.5 cm2
- Type of wrap if used: elastic tape
REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: The animal was killed after 96 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: The animal was killed after 96 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: The animal was killed after 96 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: The animal was killed after 96 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- see irritation / corrosion parameter
see irritation / corrosion parameter
Animals 2 and 3 showed a gray black skin discolouration after 1 h observation time.
Animals 2 and 3 showed bloody eschar at the site of application after 24 h observation time.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The study is well performed and gives following results for the Endpoint:
The substance is corrosive - Executive summary:
For Sodium tolyltriazolate a well-conducted in vivo study is available showing skin corrosion. This means that a similar result for Sodium Benzotriazolate can be anticipated.
Sodium Benzotriazolate is skin corrosive.
A DNEL for oral, dermal and/or inhalation route can be based on this information.
Classification and labeling are needed for this endpoint.
A risk characterization will be performed because the substance is classified.
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