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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Scantox, Lille Skensved, Denmark

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HR 98/660032
- Physical state: white to pale yellowish crystals
- Lot/batch No.: 50391499
- Expiration date of the lot/batch: Dec 1999
- Storage condition of test material: in refrigerator in the dark

Test animals

Species:
rabbit
Strain:
other: MOL:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M&B, Ejby, DK-4623 Lille Skensved, Denmark
- Weight at study initiation: 2.2-2.4 kg
- Housing: individual in PPO/HIPS cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 55 +- 15%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 14 Dec 1998 To: 01 January 1999

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Ethanol 96% and Diethyl phthalate (1:1)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test item was moistened with 0.5 mL vehicle, or 0.5 mL of the test article solution (if diluted), were applied
- Concentration (if solution): 2, 5, 10, 25 and 100%

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1 hour after exposure period as well as 24, 48 and 72 hours after exposure period
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 10x10 cm, 6 sites were selected on this area
- Type of wrap if used: gauze patches secured with 2.5 cm adhesive tapes

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water and mild soap
- Time after start of exposure: 4 hours after exposure

SCORING SYSTEM: Erythema and Eschar formation: Score 0 to 4; Oedema formation: Score 0 to 4

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No signs of irritations were observed at any of the concentrations tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
All treated skin sites were scored with 0, i.e. no irritation was induced at any of the tested concentrations. Benzophenone is therefore not subject of classification.
Executive summary:

A primary skin irritation study was performed in rabbits according to OECD 404 (1992). Benzophenone was tested at concentrations of 2, 5, 10, 25 and 100%. No signs of skin irritation were observed at any of the concentrations tested. Therefore, no classification as skin irritant is required.