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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline (OECD 402) study, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(Feb. 1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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:

- Physical state: white powder
- Storage condition of test material: room temperature

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. Animal Production, 4332 Stein/ Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 212 -237 g
- Housing: individually; in Macrolon type 3 cages
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % (w/v) in 0.1 % (w/v) aqueous polysorbate 80

Details on dermal exposure:

TEST SITE
- Shaving: approx. 24 hours before treatment
- Area of exposure: back
- % coverage: at least 10 %
- Type of wrap if used: gauze-lined dressing was fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes (water)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 4 mL/kg bw
- Concentration (if solution): no data

Duration of exposure:

24 hours

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Mortality was monitored twice daily on week days and once on weekends. Clinical signs were monitored daily
- Frequency of weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Highest dose tested. No mortality occurred and the only clinical sign manifested was piloerection (fully reversible within 1 day)

Mortality:

No mortalities occurred.

Clinical signs:

other: - Slight piloerection was seen. This is common symptom in acute dermal tests. The animals recovered within 1 day.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Any other information on results incl. tables

Table 1: Table of mean body weights (n = 5); acute dermal toxicity

		Dose
		2,000 (mg/kg bw)
Day 0	♂	219 ± 6.1
	♀	223 ± 9.0
Day 7	♂	269 ± 10.7
	♀	248 ± 14.0
Day 14	♂	319 ± 9.3
	♀	266 ± 15.7

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met