Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral: mouse LD50 = ca. 2895 mg/kg bw; rat LD50: > 10000 mg/kg bw (Caprino et al., 1975; Opdyke, 1979)
Acute toxicity, dermal: rabbit LD50: 3535 mg/kg bw (Opdyke, 1979)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Some methodical details are missing
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
The study was performed using 8 animals per group with 5 dose groups. The post-observation period was 7 days.
GLP compliance:
no
Remarks:
Study from 1975 (at this time GLP was not compulsory)
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
Swiss
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 19-25 g
- Fasting period before study: 16 hours
Route of administration:
oral: gavage
Vehicle:
other: gum arabicum
Details on oral exposure:
no further data
Doses:
no data
No. of animals per sex per dose:
8 animals per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis with confidence limits
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 2 895 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 441 - <= 3 434
Mortality:
not further specified
Clinical signs:
In lethal doses, benzophenone induced sedation, progressive depression of motor activity, unstable gait, tremors and respiratory impairment.
Body weight:
not further specified
Gross pathology:
No gross lesions detected at necropsy
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral toxicity in mice (LD50) was 2895 mg/kg bw
Executive summary:

Benzophenone was administered by oral gavage as single application to Swiss mice to determine the acute toxicity. A necropsy was performed 7 days after administartion of the test item. Clinical signs at lethal doses were sedation, progressive depression of motor activity, unstable gait, tremors and respiratory impairment.

The acute oral toxicity in mice was determined by Probit analysis at 2895 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 895 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Only results given (methodical details missing)
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method not further specied
GLP compliance:
no
Test type:
other: not further specified
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not further specified
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
not further specified
Duration of exposure:
not further specified
Doses:
not further specified
No. of animals per sex per dose:
not further specified
Control animals:
not specified
Details on study design:
not further specified
Statistics:
not further specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 535 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 007 - <= 6 226
Mortality:
not further specified
Clinical signs:
not further specified
Body weight:
not further specified
Gross pathology:
not further specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal toxicity (LD50) in rabbits was reported to be at 3535 mg/kg bw.
Executive summary:

In this review the dermal LD50 value for benzophenone in rabbits was given with 3535 mg/kg bw. Thus benzophenone is practically non-toxic in the rabbit after a single dermal dose and is thus not subject of classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 535 mg/kg bw

Additional information

Acute oral toxicity

In an acute oral toxicity study with a study design comparable to OECD Guideline 401, benzophenone was administered to Swiss mice via gavage. The LD50 value was ca. 2895 mg/kg bw. Clinical signs at lethal doses were sedation, progressive depression of motor activity, unstable gait, tremors and respiratory impairment (Caprino et al., 1975). In a study with rats the LD50 value was given with > 10000 mg/kg bw (Opdyke, 1979).

Acute inhalation toxicity

No studies are available with exposure to benzophenone by inhalation.

Acute dermal toxicity

In an older study with limited documentation a LD50 value of 3535 mg/kg bw was given for rabbits (Opdyke, 1979).

Justification for classification or non-classification

Acute oral toxicity

Based on the data provided by Caprino et al. (1975) and Opdyke (1979) with LD50 values of > 2895 mg/kg bw, there is no need for a classification according to the criteria of EC Directive 1272/2008 and of the GHS.

Acute toxicity inhalation

Classification not possible (lack of data)

Acute dermal toxicity

Based on the data provided by Opdyke (1979) with a LD50 value 3535 mg/kg bw, there is no need for a classification according to the criteria of EC Directive 1272/2008 and of the GHS.