Phenol, 2-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-5-[(2-ethylhexyl)oxy]-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: HanBrl: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fuellinsdorf / Switzerland- Age at study initiation: males = 8 weeks, females = 7-8 weeks- Weight at study initiation: males = 215.9 - 233.9 g, females = 180.1 - 210.7 g- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 57/02 (Provimi Kliba AG, Kaiseraugst/ Switzerland) ad libitum.- Water (e.g. ad libitum): Community tap water from Fuellinsdorf ad libitum.- Acclimation period: one weekENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on dermal exposure:

TEST SITE- % coverage: approximately 10 % of the total body surfaceREMOVAL OF TEST SUBSTANCE- Washing (if done): with lukewarm tap water- Time after start of exposure: Twenty-four hours after the application.TEST MATERIAL- Amount(s) applied (volume or weight with unit): 6.66 g/kg bw- Concentration (if solution): 30 %

Duration of exposure:

24 hours

Doses:

2000 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: Clinical signs were noticed daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. Weighing was done on test days 1 (prior to administration), 8 and 15. Mortality / Viability was notice daily during acclimatization and twice daily during days 1-15.- Necropsy of survivors performed: yes, at the end of the observation period

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met