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Toxicological information

Skin irritation / corrosion

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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:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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

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.