Zinc EDDHA

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-09-13 to 1993-10-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts

EC Number:

283-044-5

EC Name:

Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts

Cas Number:

84539-55-9

Molecular formula:

non specified (UVCB substance)

IUPAC Name:

Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts

Test material form:

other: Black red, fine grained and free-flowing solid

Details on test material:

- Test article: CGA65047 SG 100, (A-5787 A); identical to FeNaEDDHA
- Additional specification: Sesquestrene 138 Fe 100 SG
- Physical state: granules; miscible in water
- Analytical purity: 100% (UVCB)
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Aimal Production, 4332 Stein/ Switzerland
- Age at study initiation: Young adult
- Weight at study initiation: 200 to 261 g
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: The animal were individually housed in Macrolon cages type 3, with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau /SG, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back of the rat
- % coverage: at least 10 % of the body surface
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: after 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg (male and female)

No. of animals per sex per dose:

5 males/5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animal were observed daily. Bodyweights were recorded immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: toxicity and pharmacological effects, body weight, gross pathology

Statistics:

Not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured in this study.

Clinical signs:

other: other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests.

Gross pathology:

At necropsy no deviations from normal morphology were found.

Other findings:

No other findings were noted.

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

according to EU GHS

Conclusions:

The LD 50 is greater than 2000 mg/kg body weight.

Executive summary:

The toxic effects of FeNaEDDHA in the albino rats were investigated according to the OECD Guideline 402 on Acute Dermal Toxicity. Ten healthy albino rats were dosed dermally in a limit test with a single concentration of test material at a dose level of 2000 mg/kg body weight.

Approx. 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.The test substance was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water.

The animals were observed daily for signs of mortality, toxicity and pharmacological effects. Bodyweights were recorded immediately before application and on days 7 and 14. All animals were examined for gross pathology.

All animals survived the 2000 mg/kg bw dermal application. Piloerection and hunched posture were seen in the study, being common symptoms in acute dermal tests. Body weight changes were normal. The animals recovered within 1 day. At necropsy, no deviations from normal morphology were found. The LD50 is greater than 2000 mg/kg body weight.