Benzophenone

Endpoint summary

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

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 or test system 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:

other: In lethal doses, benzophenone induced sedation, progressive depression of motor activity, unstable gait, tremors and respiratory impairment.

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 or test system 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:

other: 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.