Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1980-02-26 to 1980-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP, similar to OECD TG 402

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-phenylbutan-2-one
EC Number:
219-847-4
EC Name:
4-phenylbutan-2-one
Cas Number:
2550-26-7
Molecular formula:
C10H12O
IUPAC Name:
4-phenylbutan-2-one
Details on test material:
- Name of test material (as cited in study report): Benzyl acetone
- Physical state: clear liquid, specific gravity = 0.98
- Impurities (identity and concentrations): not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Nicholas Helf
- Age at study initiation: 9 weeks
- Weight at study initiation: 2.3 -2.8 kg
- Fasting period before study: no
- Housing: 2/cage in suspended wire mesh cages
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 200 square cm
- % coverage: approximately 10 % of the body surface
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure site was wiped, but not washed
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 g/kg bw
Duration of exposure:
24 h
Doses:
5.0 g/kg bw
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: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the observation period of 14 days.
Clinical signs:
Isolated instances of diarrhea and mucousy diarrhea were noted during the study. Nine animals were normal on Day 14.
Body weight:
Body weight changes were within expected limits.
Gross pathology:
All animals, sacrificed on Day 14, were normal internally. One animal had scaly skin and one animal had ulcerated treated skin.
Other findings:
Skin reactions were variable ranging from slight to severe.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely non toxic to rabbits in an acute dermal toxicity test with an LD50 value of >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

Ten (5 male and 5 female) healthy, New Zealand White rabbits with initial body weights of 2.3-2.8 kilograms received one dermal application of test material. Food and water were available freely. The test material was applied to clipped, intact or abraded abdominal skin under occluded patches for 24 hours of contact. The exposure site was wiped, but not washed, to remove excess material. Observations for mortality and/or systemic effects were made daily for 14 days. Dermal reactions were scored at 24 hours by the Draize scoring system and were variable ranging from slight to severe. Body weights were recorded pretest and at 14 days. Body weight changes were within expected limits. Gross necropsy was conducted on all animals, where one animal had ulcerated treated skin and one animal had scaly treated skin. 5 g/kg no effects, acute dermal LD50 >5 g/kg.