Zinc, [1,2,3-propanetriolato(2-)-.kappa.O1,.kappa.O2]-, homopolymer, stereoisomer

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 27, 2009 to October 14, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

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(2+) 3-hydroxypropane-1,2-bis(olate)

EC Number:

700-107-9

Cas Number:

87189-25-1

Molecular formula:

(C3H6O3Zn)n

IUPAC Name:

zinc(2+) 3-hydroxypropane-1,2-bis(olate)

Details on test material:

- Substance type: Organic
- Physical state: Powder
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain as stated in the report: Rat/Wistar/CrI:WI (Han) SPF
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males: approximately 8 weeks, females: approximately 12 weeks
- Weight at study initiation: males: mean weight: 251.4 g (Sd: 1.52), females: mean weight: 203.8 g (Sd: 5.93)
- Housing: single housing in Makrolon cage, type III
- Diet ad libitum: VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany
- Water ad libitum: tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental pahse
- Other information: The female animals were nulliparous and non-pregnant

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26°C
- Humidity (%): 20-80%
- Air changes (per hr): air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

Double distilled

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: about 40 cm2 (corresponds to at least 10% of the body surface)
- Type of wrap if used: semi occlusive dressing (the bandage consists of four layers absorbent gauze, Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.86 g/kg
- Concentration (if solution): 2000 mg/kg bw

VEHICLE
- Double distilled water

TEST SUBSTANCE PREPARATION:
The test-item preparation was produced for the application group shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer.
The homogeneity of the test-item preparation during application was provided by stirring with a magnetic stirrer.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for mortality and clinical symptoms: several times on the day of administration and at least once daily thereafter each working day for the individual animals.
- Frequency of weighing: shortly before administration (day 0) , weekly thereafter and on the last day of observation.
- Necropsy: all animals were sacrificed and subjected to gros-pathology on the last day of the observation period.

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.
No statistical analysis was performed.

Results and discussion

Preliminary study:

not performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: None of the animals died. No clinical signs were observed.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs and no local effects were observed during clinical examination.

Gross pathology:

No macroscopic findings were noted at necropsy.

Any other information on results incl. tables

Table 1: Mean body weights in gram (Dose level: 2000 mg/kg bw)

Test day	0	7	14
Treated males	251 +/- 2	275 +/- 3	303 +/- 3
Treated females	204 +/- 6	208 +/- 5	216 +/-8

Body weights on day one were assessed before application of test article.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the LD50 after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.