2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-09-19 to 2002-10-10

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-860-9

EC Name:

-

Cas Number:

474510-57-1

Molecular formula:

C21 H24 O4

IUPAC Name:

2-hydroxy-1-(4-{[4-(2-hydroxy-2-methylpropanoyl)phenyl]methyl}phenyl)-2-methylpropan-1-one

Details on test material:

- Description: slightly yellow solid
- Purity: Unknown; excluded from the statement of compliance.
- Stability of test item dilution: Stable in PEG 300 at least 1 hour.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division; CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 9 weeks; Females: 10 weeks
- Weight at study initiation (mean): Males: 257.9 g; Females: 202.18 g
- Fasting period before study: no
- Housing: In groups of 5 rats/sex in Makrolon type 4 cage.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 34/02
- Water: Community tap water from Füllinsdorf ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours fluorescent light/ 12 hours dark, music during the light period


IN-LIFE DATES: From: 19-Sept-2002 To: 10-Oct-2002

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

(PEG 300)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10 % of the total body surface
- % coverage: no data
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 500 mg/mL per kg bw, based on dose volume
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): no data
- Lot/batch no. (if required): 4333371/1 20602
- Purity: no data

Duration of exposure:

single dose

Doses:

2000 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: 15 days
- Frequency of observations and weighing: Mortality / Viability: daily during acclimatization and twice daily during days 1 -15; body weights:on test days 1 (prior to administration), 8 and 15; clinical signs: daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

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.

Any other information on results incl. tables

The median lethal dose of the test item after single dermal administration to rats of both sexes, observed over a period of 15 days is: LD50 (rat): greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Conclusions:

The dermal acute LD50 of the test material is >2000 mg/kg bw in Rats (both sexes).

Executive summary:

In this guideline (OECD 402) study conducted with GLP certification, the acute dermal LD50 of the test material (EC 444-860-9) to the rat was determined to be >2000 mg/kg bw (both sexes). The test material was administered under occlusive conditions as a limit test (2000 mg/kg bw) to male and female for 24 hours, with a post application observation period of 15 days. The result of the test does not trigger classification of the test material as acutely toxic according to the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).