2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol

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: Comparable to guideline methods with acceptable restrictions - analytical purity of test article was not given in the report

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 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(dosing volume > 10 mL/kg bw, 10/14 hour light/dark cycle, acclimation period = 4 days)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol

EC Number:

274-570-6

EC Name:

2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol

Cas Number:

70321-86-7

Molecular formula:

C30H29N3O

IUPAC Name:

2-(2H-1,2,3-benzotriazol-2-yl)-4,6-bis(2-phenylpropan-2-yl)phenol

Test material form:

solid

Details on test material:

- Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid

Specific details on test material used for the study:

- Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid

Test animals

Species:

rat

Strain:

other: Tif RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba Geigy Ltd.
- Age: 7 to 8 wks
- Mean weight range at study initiation: 173 - 187 g (♂) and 175 - 184 g (♀)
- Fasting period before study: overnight
- Housing: 5/cage (macrolon cages type V)
- Diet: ad libitum; NAFAG Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(400)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10, 20, 30 %
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: Test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 - 25.8 mL/kg bw

DOSAGE PREPARATION
A test substance suspension was prepared. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

1,000, 2,150, 4,640 and 7,750 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: Physical condition and rate of deaths were monitored throughout the whole observation period.
- Frequency of weighing: body weights were recorded immediately prior to dosing (control weights) and 7 and 14 days post treatment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 750 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Highest dose tested. Mortality did not occur in any dose group.

Mortality:

No mortality was detected in any group

Clinical signs:

other: - 1,000 mg/kg bw: sedation, dyspnoea, exophthalmos, ruffled fur and curved body position (symptoms starting as early as 1 hour post dosing, fully reversible within 8 days) - 2,150 and 4,640mg/kg bw: sedation, dyspnoea, exophthalmos, ruffled fur and curved

Gross pathology:

No substance related gross organ changes were seen at the necropsy of sacrificed animals

Any other information on results incl. tables

Table 1: Table of Body weights (acute oral toxicity)

		Dose (mg/kg bw)
		1,000	2,150	4,640	7,750
Day 1	♂	187 ± 7.1	173 ± 2.3	175 ± 3.7	181 ± 1.6
	♀	184 ± 4.1	179 ± 1.3	175 ± 2.8	163 ± 4.5
Day 7	♂	251 ± 9.6	233 ± 9.8	250 ± 8.3	237 ± 1.8
	♀	219 ± 6.1	216 ± 5.2	210 ± 7.5	194 ± 6.6
Day 14	♂	289 ± 17.0	285 ± 11.6	298 ± 17.2	288 ± 8.7
	♀	248 ± 7.0	239 ± 4.0	233 ± 9.7	217 ± 7.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met