Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion
Not irritating in a study performed with rabbits according to OECD Guideline 404 (Kaaber, 1999).
Eye irritation / corrosion
For benzophenone there are no valid studies available performed with experimental animals. In one study (Eastman Kodak Co., 1984; results are limited due to missing details) the application of several crystals of benzophenone into the conjunctival sac caused only a slight reaction. In the other study (Upjohn Co., 1984) the treatment caused no eye irritation. Based on the widespread exposure and the long term experience with benzophenone in humans, it can be concluded that the substance is not a significant eye irritant and negates the need for any further animal testing with respect to this endpoint.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
For benzophenone there are no valid studies available performed with experimental animals. In one study (results are limited due to missing details) the application of several crystals of benzophenone into the conjunctival sac caused only a slight reaction. In the other study the treatment caused no eye irritation. Based on the widespread exposure and the long term experience with benzophenone in humans, it can be concluded that the substance is not a significant eye irritant and negates the need for any further animal testing with respect to this endpoint.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

A primary skin irritation study was performed in rabbits according to OECD 404 (Kaaber, 1999). Benzophenone was tested at concentrations of 2, 5, 10, 25 and 100%. All treated skin sites were scored with 0, i.e. no irritation was induced at any of the tested concentrations.

Eye irritation / corrosion

For benzophenone there are no valid studies available performed with experimental animals. In one study (Eastman Kodak Co., 1984; results are limited due to missing details) the application of several crystals of benzophenone into the conjunctival sac caused only a slight reaction. In the other study (Upjohn Co., 1984) the treatment caused no eye irritation. Based on the widespread exposure and the long term experience with benzophenone in humans, it can be concluded that the substance is not a significant eye irritant and negates the need for any further animal testing with respect to this endpoint.

Respiratory irritation

No data available.

Justification for classification or non-classification

Skin irritation / corrosion

Based on the data provided by Kaaber (1999), there is no need for a classification according to the criteria of EC Directive 1272/2008 and of the GHS.

Eye irritation / corrosion

For benzophenone there are no valid studies available performed with experimental animals. Based on the widespread exposure and the long term experience with benzophenone in humans, it can be concluded that the substance is not a significant eye irritant, i.e. there is no need for a classification according to the criteria of EC Directive 1272/2008 and of the GHS, and negates the need for any further animal testing with respect to this endpoint.

Respiratory irritation

Classification not possible due to lack of data. However, based on the widespread exposure and the long term experience with benzophenone in humans, it can be concluded that the substance is not a significant respiratory irritant, i.e. there is no need for a classification according to the criteria of EC Directive 1272/2008 and of the GHS.