Zinc dibenzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zinc oxide

EC Number:

215-222-5

EC Name:

Zinc oxide

Cas Number:

1314-13-2

Molecular formula:

ZnO

IUPAC Name:

oxozinc

Constituent 2

Reference substance name:

Z-Cote HP1

IUPAC Name:

Z-Cote HP1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Charles River, Sulzefeld, Germany- Age at study initiation: 10 - 11 weeks- Weight at study initiation: males (mean): 308.92 g, females (mean): 193.28 g- Housing: 2 rats of same sex per cage, wooden absorbing bedding- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 4 weeksENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 2°C- Humidity (%): 55 +/- 15%- Air changes (per hr): fully airconditioning- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE- Area of exposure: backREMOVAL OF TEST SUBSTANCE- Washing (if done): water- Time after start of exposure: 24 hTEST MATERIAL- Amount(s) applied (volume or weight with unit): 2000mg/kg bw- Concentration (if solution): 0.5mg test item in 400µl corn oil- Constant volume or concentration used: no- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: untreated skin of same animal

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: twice a day, once on weekends- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Means and standard deviation were calculated using standard statistical tests.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred

Mortality:

not observed

Clinical signs:

other: slight signs of general discomfort as often seen in dermal toxicity studies, the general health status was good throughout the study

Gross pathology:

no abnormalties detected

Any other information on results incl. tables

During the present study no mortality occured and there were no indications of systemical toxicity, no effects regarding the body weight and neither clinical signs nor pathological findings observed. The LD50 is therefore estimated to be > 2000mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Executive summary:

2000 mg/kg bw of the test item were semiocclusively administered for 24 hours as pasty formulation in corn oil to the shaved and defaffed back of

5 female and 5 male rats. After the end of the 24 -hour exposure period the test item paste was recovered as effectively as possible using water and the animals were observed for 14 days.

During the present study no mortality occured and there were no indications of systemical toxicity, no effects regarding the body weight and neither clinical signs nor pathological findings observed. The LD50 is therefore estimated to be > 2000mg/kg bw.