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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992
Reference Type:
secondary source
Title:
Toxicological Evaluations Vol. 13
Author:
BG Chemie
Year:
1998
Bibliographic source:
Springer-Verlag Berlin Heidelberg, ISBN 3-540-62658-1

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period 16 days
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fluorobenzene
EC Number:
207-321-7
EC Name:
Fluorobenzene
Cas Number:
462-06-6
Molecular formula:
C6H5F
IUPAC Name:
fluorobenzene
Details on test material:
- Name of test material (as cited in study report): Fluorobenzene
- Analytical purity: 99.7%
- Batch No. 01420
- Physical state: colourless liquid
- Storage condition of test material: in the refrigerator at 4°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Limited, Wyton, Huntingdon
- Age at study initiation: young adult
- Housing: single housing in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet: Standard Rabbit Diet (Special Diets Services, Witham, Essex) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 52 (mean)
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animals
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted
Duration of treatment / exposure:
4 hours
Observation period:
16 days; skin reactions were assessed 1 h, 24 h, 48 h, 72 h, 7 d and 16 d after patch removal
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 cm x 2.5 cm patch of gauze covered with Micropore tape, and the trunk was loosely bound with Elastoplast Elastic Bandage


REMOVAL OF TEST SUBSTANCE
- Washing: with water dampened tissues
- Time after start of exposure: 4 hours


SCORING SYSTEM: OECD recommended scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 16 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight erythema was noted in one rabbit 72 h and 7 days after patch removal. This reaction had fully reversed by 16 days after patch removal. No other reactions were noted.

Any other information on results incl. tables

Skin Reaction Scores:

Rabbit No.

Erythema

Edema

1 h

24 h

48 h

72 h

7 d

16 d

1 h

24 h

48 h

72 h

7 d

16 d

1

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

3

0

0

0

1

1

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Fluorobenzene is practically non-irritationg to rabbit skin.