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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1987 - May 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Relatively well reported study; 3 days of observation instead of 14 days.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

- sex of rabbits is unknown
- no initial and confirmatory test

GLP compliance:

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:

- Name of test material (as cited in study report): Bolikel FE
- Physical state: brown/red crystals
- Lot/batch No.: Batch No. 2
- Storage condition of test material: at ambient temperature, under dry conditions
- Other: received on February 27, 1987 (4 x 375 g)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, England
- Age at study initiation: 3 months old
- Weight at study initiation: 2.76 - 2.89 kg
- Housing: individually housed in suspended stainless steel cages
- Diet (e.g. ad libitum): free access (to S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (range 15 - 23)
- Humidity (%): 55 (range 40 - 70)
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light per day


IN-LIFE DATES: From: April 28, 1987 To: May 1, 1987

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: moistened with 0.2 ml distilled water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable (moistened with 0.2 ml distilled water

Duration of treatment / exposure:

4 hours

Observation period:

3 days (1 hour, 24, 48 and 72 hours after patch removal)

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: gauze patch was 3 x 2 cm
- % coverage: no info
- Type of wrap if used: The rabbit was securely restrained by a technician. Two test sites (6 x 6 cm) were marked on either side of the clipped area of dorsum and moistened by direct application of 0.2 ml distilled water per test site. A single dose (0.5 g) was impregnated onto an unmedicated gauze patch (3 x 2 cm) and was held in place on the left test site by strips of Blenderm (3-M Company). The right test site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated. Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressings were removed after four hours exposure. Where necessary, the treatment sites were gently washed with warm water and dried with paper towels to remove excessive amounts of test material adhering to the skin.
- Time after start of exposure: 4 hours


SCORING SYSTEM: see below

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72 h after patch removal

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72 h after patch removal

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No other dermal irritation response was observed in any animal.

Other effects:

No.

Any other information on results incl. tables

Summary of dermal lesions on clipped and intact skin (following 4-h application).

no.	Effect	Hour	Days after application						Mean score erythema 24/48/72 h	Mean score oedema 24/48/72 h
		1	1	2	3	7	14
523M	Erythema/ eschar Oedema	0 0	0 0	0 0	0 0	- -	- -		0	0
524M	Erythema/ eschar Oedema	1 0	0 0	0 0	0 0	- -	- -		0	0
525M	Erythema/ eschar Oedema	0 0	0 0	0 0	0 0	- -	- -		0	0
Mean Group									0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the results of the present study, it was concluded that Bolikel FE induced practically no skin irritation, so the test material is classified as non-irritant to the skin. Reversibility of the slight skin effect in one animal occurs.

Executive summary:

A primary dermal irritation study was conducted on three male white rabbits using test substance Bolikel FE. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.

Each animal received 0.5 g test material. A single 4 -hour, semi-occluded application of the test material to the intact skin produced immediately after patch removal very slight erythema at the test site of one animal. This effect disappeared after 24 hours after patch removal. Necrosis and ulceration were not reported.

Based on the results of the present study, it was concluded that Bolikel FE induced practically no skin irritation, so the test material is classified as non-irritant to the skin. Reversibility of the slight skin effect in one animal occurs.