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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
August 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3'-(trifluoromethyl)acetophenone
EC Number:
206-490-4
EC Name:
3'-(trifluoromethyl)acetophenone
Cas Number:
349-76-8
Molecular formula:
C9H7F3O
IUPAC Name:
1-[3-(trifluoromethyl)phenyl]ethan-1-one
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: HanIbm:WIST
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: approx. 213-240 g
- Housing: individual (Macrolon Typ 3 cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12

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
- Area of exposure: 6 x 6 cm
- % coverage: 10 of body surface
- Type of wrap if used: Isocomfort self-adhesive wrap

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 400 mg per 100 g bw
- Concentration (if solution): 5011 mg with 5000 mg vehicle

Duration of exposure:
14-day post-treatment observation period
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females rats
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
other: No remarkable clinical observations.
Gross pathology:
No observable abnormalities.
Other findings:
No remarkable findings at the application site.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Groups of 5 male and 5 female Wistar rats were administered a single dose of the test item by dermal application at a dose level of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14-day post-treatment observation period. There was no mortality in the study. Therefore, the acute dermal LD50 value was determined to be > 2000 mg/kg bw.