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Description of key information

An analogue (Sodium Tolyltriazolate) is skin corrosive.
Following the Read across approach the substance is skin corrosive.
Eye irritation was not tested as the substance is skin corrosive (According to EC 2006/1907, Annex IVV,8.2 Column 2).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
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
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
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.
Interpretation of results:
Category 1B (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The substance has a high pH-value when dissolved, an analogue (Sodium Tolyltriazolate) with the same pH has been tested,
therefore the read across to this analogue is selected.

Justification for selection of eye irritation endpoint:
The substance is skin corrosive, therefore no study is needed.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 the substance is classified as Skin Corr. 1B and Eye Damage 1.

For this classification the substance has to be labelled with the signal word “Danger” and the pictogram "GHS05".

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