2-(2H-benzotriazol-2-yl)-4-tert-butylphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 February - 15 March 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2H-benzotriazol-2-yl)-4-tert-butylphenol

EC Number:

221-574-0

EC Name:

2-(2H-benzotriazol-2-yl)-4-tert-butylphenol

Cas Number:

3147-76-0

Molecular formula:

C16H17N3O

IUPAC Name:

2-(2H-1,2,3-benzotriazol-2-yl)-4-tert-butylphenol

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 169 - 198 g
- Fasting period before study: Overnight before dose administration
- Housing:Solid-floor polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): 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 hours light / 12 hours dark

IN-LIFE DATES: From: 22 February 2017 To: 15 March 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Test material did not dissolve in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Main study was based on no deaths seen in sighting study at 2000 mg/kg

Doses:

2000 mg/kg

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: Clinical observations 1, 2 and 4 hours after dosing; daily thereafter
Bodyweights recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

Sighting study conducted at 2000 mg/kg

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality seen in any animal dosed at 2000 mg/kg

Clinical signs:

other: Hunched posture observed in the initial treated animal up to 4 hours after dosing. No clinical signs of toxicity seen in the other four animals.

Gross pathology:

No abnormalities seen in any animals

Applicant's summary and conclusion

Interpretation of results:

other: Test material not classified as no deaths seen up to 2000 mg/kg

Conclusions:

The acute oral median lethal dose (LD50) of the test item in female Wistar rats was estimated to be greater than 2000 mg/kg body weight.