2-(2H-benzotriazol-2-yl)-p-cresol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Jan. 23, 1978 to Jan. 23, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

: no individual data reported, animals were acclimatized for 4 days, no rational for the selection of the doses , signs and symptoms of toxicity were noted but not discussed, and final body weights were not reported

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2H-benzotriazol-2-yl)-p-cresol

EC Number:

219-470-5

EC Name:

2-(2H-benzotriazol-2-yl)-p-cresol

Cas Number:

2440-22-4

Molecular formula:

C13H11N3O

IUPAC Name:

2-(2H-1,2,3-benzotriazol-2-yl)-4-methylphenol

Test material form:

solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): TK 10047
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:

rat

Strain:

other: Tif; RAIF(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 160 to 180 g
- Housing: groups of 5 in macrolon 5 cages
-Fasting prior to adminstration: overnight
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

4640, 7750, 10,000 mg/kg body weight

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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

none

Results and discussion

Preliminary study:

No preliminary study

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Mortality:

1 animal in the high dose group died at 48 hrs, 2 animals in the high dose group died at 7 days and 2 animals died at 14 days

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. Sedation became more accentuated as the dose was increased. The surviving animals recovered within 8 to 10 days. They were submitted a

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met