Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
29.04.1986 - 13.05.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloro-α,α,α-trifluorotoluene
EC Number:
202-642-9
EC Name:
3-chloro-α,α,α-trifluorotoluene
Cas Number:
98-15-7
Molecular formula:
C7H4ClF3
IUPAC Name:
1-chloro-3-(trifluoromethyl)benzene
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd., Abbots Ripton RD; Wyton, Huntingdon, Cambs.
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- % coverage:
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: after incubation period

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 1.3 - <= 1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritant.