Calcium dibenzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

Limited study summary, no GLP, deviations compared to OECD 402

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid

EC Number:

200-618-2

EC Name:

Benzoic acid

Cas Number:

65-85-0

Molecular formula:

C7H6O2

IUPAC Name:

Benzoic acid

Test material form:

not specified

Details on test material:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2311 - 2812 grams
- Diet (ad libitum)
- Water (ad libitum)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the back
- Type of wrap if used: gauze bandages and Saran Wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): undiluted
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 male and 2 female per dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Other examinations performed: body weight,organ weights

Statistics:

None stated

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No information provided

Gross pathology:

No information provided

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the dermal route.

Executive summary:

4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.

The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.