Benzotriazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guidance study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Benzotriazole

EC Number:

202-394-1

EC Name:

Benzotriazole

Cas Number:

95-14-7

Molecular formula:

C6H5N3

IUPAC Name:

benzotriazole

Test material form:

other: granule

Details on test material:

- Name of test material (as cited in study report): 1,2,3-Benzotriazole-REACH 01

- Physical state: solid, granule
- Analytical purity: 99.87 %
- Lot/batch No.: 111254/112649
- Expiration date of the lot/batch: Nov 2012
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier
- Age at study initiation: 8 or 9 weeks
- Weight at study initiation: 189 to 223 g

- Fasting period before study: 1 d
- Housing: solid-bottomed clear polycarbonate cages with stainless steel mesh lid
- Diet: M20, SDS ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 300 mg or 2 g in 10 ml olive oil
- Amount of vehicle (if gavage): 10 ml / kg bw

Doses:

300 mg and 2 g /kg bw

No. of animals per sex per dose:

3 animals per dose, no consideration on sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at day 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no statistics were performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: LD50 cut-off

Effect level:

ca. 500 mg/kg bw

Based on:

other: OECD guideline

Mortality:

At a dose of 2 g /kg bw, all animals died three hours after exposure.
At a dose of 300 mg/kg bw, all animals survived.

Clinical signs:

other: In the hours after exposure, the animals showed a decrease or absence in spontaneous activity, in muscle tone, in righting reflex and in Preyer's reflex, mydriasis, lacrymation, bradypnea and partial ptosis. In the group treated with 300 mg / kg bw, not

Gross pathology:

The animals treated with a dose of 2 g/kg bw showed a thinning of the forestomach and corpus, associated with a white coloration and black spots.
No changes were observed for the animals treated with 300 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item 1,2,3-Benzotriazole is higher than 300 mg/kg and lower than 2000 mg /kg body weight by oral route in the rat.
In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.