2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-06-24 - 1992-08-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol

EC Number:

411-380-6

EC Name:

2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol

Cas Number:

147315-50-2

Molecular formula:

C27 H27 N3 O2

IUPAC Name:

2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol

Test animals

Species:

rat

Strain:

other: albino rats (Tif: RAI f (SPF))

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Stein, Switzerland
- Weight at study initiation: 216 - 290 g
- Housing: Individually in Macrolon cages type 3 with standardized soft wood bedding
- Diet: Standard diet, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Photoperiod: 12 hour/day light cycle

IN-LIFE DATES: From: 1992-07-14/1992-07-23 To: 1992-07-28/1992-08-06

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

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

Details on dermal exposure:

TEST SITE
- Pretreatment: Area of exposure was shaved 24 hours before application
- Area of exposure: backs of the animals
- % coverage: 10
- Type of wrap: On test day 1 the test item was evenly dispersed on the skin and was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned with lukewarm tap water and the skin reaction was appraised.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Because of the high viscosity of the test item mixture, only 1333 mg/kg bw could be applied, respecting the maximal application volume of 4 mL/kg bw.

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

Duration of exposure:

24 hours

Doses:

1333 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Observations and records:
Mortality: daily
Signs and symptoms: daily
Body Weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

Body weight: Mean and SD

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 333 mg/kg bw

Based on:

test mat.

Mortality:

The following death rate was observed: 0 % at 1333 mg/kg bw.

Clinical signs:

other: The following clinical signs were observed: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.

Gross pathology:

At necropsy, a spotted thymus was found in two males. No deviations from normal morphology were found in the remaining animals.

Any other information on results incl. tables

Based on the observations, the dermal LD50 value was to be greater than 1333 mg/kg bw.

Because of the high viscosity of the test item mixture, only 1333 mg/kg bw could be applied, respecting the maximal application volume of 4 mL/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

In an acute dermal toxicity study groups of male and female rats (5/sex) were dermally exposed to the test item (as described in section 1.2) in a standard vehicle for 24 hours to at least 10% of body surface area at a limit dose of 1333 mg/kg bw. Animals then were observed for 14 days. Clinical signs consisted of transient piloerection and hunched posture regarded as common symptoms in acute testing. No mortality occurred in this study. At necropsy, no observable abnormalities were noticed in eight animals and a spotted thymus was found in two males. Based on these observations, the dermal LD50 value of the test item was greater than 1333 mg/kg bw.
Dermal LD50: > 1333 mg/kg bw (per sex and combined)

This study is classified as acceptable. It satisfies the guideline requirement for an acute dermal toxicity study according to OECD 402.