Sodium 1H-benzotriazolide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-performed study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium methylbenzyltriazole

IUPAC Name:

Sodium methylbenzyltriazole

Constituent 2

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
- Lot/batch No.: 150-5-45
- Storage condition of test material: tighty closed container

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Small Stock, Inc., Pea Ridge, Arkansas
- Age at study initiation: no data
- Weight at study initiation: 2.6 to 2.8 kg
- Fasting period before study: no
- Housing: stainless steel cages, individual
- Diet: Purina Rabbit Chow ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.33
- Humidity (%): 35 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of animals
- Type of wrap if used: gauze, hypoallergenic tape, plastic, tape and elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with paper towel and water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, weighing on the day of treatment, 7 and 14 days after
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no statistics performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortalities occured

Clinical signs:

other: ataxia in all animals, salivation and a nasal discharge in some. These signs were not noted any longer at the 24-hour observation period. Edema was noted only on day 1. Erythema and discoloration of the back were apparent from day 1 to day 14.

Gross pathology:

no systemic signs of toxicity except signs of toxicity of the integumentary system: Erythema and discoloration of the back

Applicant's summary and conclusion

Conclusions:

For Sodium Tolyltriazlate a well-conducted in vivo study is available showing no dermal toxicity up to the limit dose of 2000 mg/kg bw.

Executive summary:

For Sodium tolyltriazolate a well-conducted in vivo study is available showing no dermal toxicity up to the limit dose of 2000 mg/kg bw. This means that a similar result for Sodium Benzotriazolate can be anticipated.

 

Sodium Benzotriazolate is not an acute dermal toxicant and the derived LD50 is set at > 2000 mg/kg bw for this endpoint.

A DNEL for oral, dermal and/or inhalation route can be based on this information.

Classification and labelling are / are not needed for this endpoint.

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