Methyl-1H-benzotriazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed and documented toxicological study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The test item is administered oral to groups of rats in different doses.
The animals are examined for 14 days post gavage and sacrificed.
All animals found dead or sacrificed are pathological analysed.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl-1H-benzotriazole

EC Number:

249-596-6

EC Name:

Methyl-1H-benzotriazole

Cas Number:

29385-43-1

Molecular formula:

C7H7N3

IUPAC Name:

5-methyl-1H-1,2,3-benzotriazole

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Preventol CI 7-100
- Physical state: solid

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 9 (male) 14 (female)
- Weight at study initiation: 174 (male) 167 (female)
- Fasting period before study: 16 hours
- Housing: Makrolon cages type III
- Diet: Altromin R1324 ad libitum except fasting period
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1.5 °C
- Humidity (%): 60 +-5 %
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 ml / kg
- Justification for choice of vehicle: DMSO is appropriate solvent for the test item

Doses:

500/630/730/800/1000/1300 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: daily, first day 1, 2, 4, 8, 24 hours
- Necropsy of survivors performed: yes

Statistics:

Calculation of LD50 and confidence interval for p < 0.05 was performed according to Rosiello, J. Tox. Environ. Health, 3, 1977, 797

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 720 mg/kg bw

Based on:

test mat.

95% CL:

> 700 - < 800

Mortality:

in the lowest dose group all animals survived, with increasing dose, the mortality increases up to 100 % in the highest dose group

Clinical signs:

other: decrease of general condition, Loss of body weight, ventral and lateral position, sedation, paralysis of rear extremities, bloodily mouth

Gross pathology:

The animals died during the study showed an irritation of the stomach mucosa

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

4(or5)-methyl-1H-benzotriazole is harmful to rats by oral gavage. The LD50 is 720 mg/kg bw