Flue dust, zinc-refining

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not applicable

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented and scientifically good . Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute dermal toxicity

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Flue dust, zinc-refining

EC Number:

273-760-6

EC Name:

Flue dust, zinc-refining

Cas Number:

69012-63-1

Molecular formula:

Not applicable - UVCB

IUPAC Name:

Zinc oxide enriched flue dust

Details on test material:

name: Probe B Wälzoxid B.U.S. Zinkrecycling Freiberg GMBH
description: grey dust
batch number: 02.07.99
expiry date: for at least one year
stability of test article: not specified
stability of test article dilution: not specified
storage conditions: at room temp (17-23°C) away from direct sunlight

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Biotechnology and Animal Breeding Division CH-4414 Füllinsdorf/Switserland
- Age at study initiation: 9 weeks for males, 12 weeks for females
- Weight at study initiation: no information
- Housing: Makrolon type-3/-4 cages
- Diet: pelleted standard Kliba 3433, batch nos 37/99 and 39/99, rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst ad libitum
- Water: community tap water from Itingen ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of the animals
- % coverage: 10% of the total body surface
- Type of wrap if used: semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): application volume/kg body weight: 4.0ml
- Concentration (if solution): 0.5g/ml
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality/viability: 4 times during test day 1 and once daily during days 2-15
body weights: on test day1 (pre-administration) , 8 and 15
clinical signs: each animal was examined for changes in appearance and behaviour four times during day 1 and once daily during days 2-15

Statistics:

No statistical analysis was used as no deaths occured

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occured during the study

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period

Gross pathology:

No macroscopic findings were observed at necroscopy

Other findings:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute dermal toxicity

Executive summary:

The purpose of this study was to assess the acute dermal toxicity of PROBE B Wälzoxid B.U.S. Zinkrecycling Freiberg GMBH when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days.

This dermal acute toxicity test according to OECD 402 with 2000mg/kg bw application of Waelz zinc oxide demonstrated that the LD50 for rats was > 2000mg/kg bw