Glycine, N,N'-1,2-ethanediylbis-, reaction products with formaldehyde, iron chloride (FeCl3) and phenol, potassium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September-October 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reported study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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:

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

EC Number:

283-041-9

EC Name:

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

Cas Number:

84539-53-7

Molecular formula:

non specified (UVCB substance)

IUPAC Name:

non specified (UVCB substance)

Details on test material:

Appearance: red-brown powder
Batch no.: LJ 18120
Stability: at least 12 months

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: not indicated
- Weight at study initiation: 269-281 g (males), 194-225 g (females)
- Fasting period before study: not applicable
- Housing: 5 per sex per cage
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50-85
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 September To: 2 October 1990

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Area of exposure: an area of roughly 5 x 10 cm was clipped
- % coverage: not indicated
- Type of wrap if used: porous gauze dressing and Eloplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
- Time after start of exposure: not indicated

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg was moistened sufficiently with physiological saline taking into account 72% active ingredient
- Concentration (if solution): not applicable
- Constant volume or concentration used: not applicable
- For solids, paste formed: no

VEHICLE: physilogical saline was used for sufficient moisturing

Duration of exposure:

24 h

Doses:

2000 mg/kg bw (taking 72% active ingredient into account) based on a RF study with 2 females

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations after patch removal: 10 min, 1, 2, 6 and 24 h, and once daily thereafter
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

None

Clinical signs:

other: No signs of erythema and oedema were observed.

Gross pathology:

Gross pathological examinations at 14 days revealed no test article-dependent findings except hair growth reduction on treated skin areas.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 is > 2000 mg/kg bw.

Executive summary:

The study was performed according to OECD Guideline 402 (Acute Dermal Toxicity) and according to GLP standards.

The test material, EDDHMAFeK was evaluated in a limit test for its acute dermal toxicity potential in rats when administered onto the skin for 24 h at a level of 2000 mg/kg (active ingredient) to a group of 5 males and 5 females. None of the rats died. No clinical signs were observed and body weight gains were as expected. Except for hair grwoth reduction on treated skin areas, no gross abnormalities were observed at necropsy 14 days after dosing.

The acute dermal median lethal dose of EDDHMAFeK to rats was found to be greater than 2000 mg/kg bodyweight (active ingredient) or greater than 2743 mg/kg bw (test article). According to OECD-GHS, EDDHMAFeK is not classified.