Registration Dossier

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:
other: GLP; OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1987
Deviations:
no
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

Constituent 1
Chemical structure
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-methylpropionyl) benzyl) 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:
No systemic or local signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
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
Remarks:
Migrated information