Sodium 5-N-butylbenzotriazole

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Annex V of ECC Directive 79/831/EEC; part B methods for determination of toxicity. Method B3 Acute Dermal Toxicity

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 5-N-butylbenzotriazole

EC Number:

404-450-2

EC Name:

Sodium 5-N-butylbenzotriazole

Cas Number:

118685-34-0

Molecular formula:

CCCCc1ccc2c(c1)nnn2[Na]

IUPAC Name:

sodium 5-butyl-1H-1,2,3-benzotriazol-1-ide

Test material form:

solid - liquid: aqueous solution

Details on test material:

Butyl benzotriazole (free acid) was prepared at a concentration of 62.5% w/v in distilled water.

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: Butyl benzotriazole (free acid), a brown powder, was prepared at a concentration of 62.5% W/V in distilled water.

FORM: dilution of powder

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Remarks:

Crl: CD (SD) BR VAF plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 202 to 250 g
- Fasting period before study: no
- Housing: individually in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): A standard laboratory rodent diet (Biosure LAD 1) ad libitum.
- Water (e.g. ad libitum): Domestic quality potable water ad libitum.

- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): THe mean daily minimum and maximumm teperatures of the animal room were 21°C and 24°C respectively.
- Humidity (%): 51%RH
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12 hrs artificial light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: 10%
- Type of wrap if used: Gauze which was held in place with an impermeable dresssing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated area of skin was decontaminated by washing in warm (30-40°C) water abd blotting dry with absorbent paper.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.2ml/kg
- Concentration (if solution): 62.5%
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

2.0 g/kg

No. of animals per sex per dose:

5 males
5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon ager dosing and at frequent intervals for the remainder of day 1 ( a period of 5 hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (erythema, oedema), body weight (day 1, 8 and 15), Macroscopic post mortem examination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

other:

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No deaths

Clinical signs:

other: There were no signs of systemic reaction to treatment

Gross pathology:

Sites of application showed no irritation reactions or other dermal changes

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity to rats of Butyl benzotriazole was tested based on what recommeded under Annex V of EEC Directive 79/831/EEC, Part B Methods for determination of toxicity. Method B3 Acute Dermal Toxicity, and the OECD guideline for Testing of Chemicals No. 402 "Acute Dermal Toxicity". A group of 10 rats was treated at 2.0 g/kg bodyweight.

The acute lethal dose to rats of Butyl benzotriazile (free acid) was found to be greater than 2.0 g/kg bodyweight.