2-oxocyclohexane-1,1,3,3-tetrapropionic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start of experiment: June 19, 1990 ; End of experiment: June 22, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-oxocyclohexane-1,1,3,3-tetrapropionic acid

EC Number:

225-833-9

EC Name:

2-oxocyclohexane-1,1,3,3-tetrapropionic acid

Cas Number:

5107-67-5

Molecular formula:

C18H26O9

IUPAC Name:

3-[1,3,3-tris(2-carboxyethyl)-2-oxocyclohexyl]propanoic acid

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The albino rabbit is the recommended species for skin irritation/corrosion studies.
- Animal strain: New Zaeland white rabbits (Chbb:NZW)
- Acclimatisation period: At least 5 days.

Group size and husbandry:
The test was performed on 3 male rabbits, chcked for normal skin conditions, weighing between 2240 to 2490 g (approx. 9-13 weeks old). The animals were housed individually in metal cages, identified by ear tattoo, kept at a constant room temperature of 20 +/- 3°C, at a relative humidity of 30-70% and on 12 hours light cycle day.

The rabbits receibed ad libitum standard rabbit pellet-Nafag N°. 814, Gossau, Switzerland and fresh water. All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.

The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972)

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Patches were moistened before application with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80.

Controls:

other: Control gauze patch was applied to the contralateral flank of each rabbits.

Amount / concentration applied:

0.5 g. of the test item was applied.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 male rabbits

Details on study design:

An area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
A gauze patch (Aprrox. 12-16 cm2) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80.
The patches were loosely covered with an aluminium foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM:

Erythema and eschar formation.

- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score: 4


Edema formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure ): 4
Total possible edema score: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 male rabbits

Time point:

other: Mean 24-72 hours

Score:

0

Remarks on result:

other: 2 male rabbits showed a score of 1 for erythema one hour after removing the bandages, after 24 hours they are fully recovered.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

mean 3 male rabbits

Time point:

other: Mean 24-72 hours

Score:

0

Irritant / corrosive response data:

Because no reactions were obsreved at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.

Other effects:

No data

Any other information on results incl. tables

Individual skin reaction scores:

Animal n°	ERYTHEMA			EDEMA
	085/M	205/M	107/M	085/M	205/M	107/M
	CF/TF	CF/TF	CF/TF	CF/TF	CF/TF	CF/TF
after 1 hr.	0/1	0/0	0/1	0/0	0/0	0/0
after 24 hrs.	0/0	0/0	0/0	0/0	0/0	0/0
after 48 hrs.	0/0	0/0	0/0	0/0	0/0	0/0
after 72 hrs.	0/0	0/0	0/0	0/0	0/0	0/0
mean 4 -72 hrs.	0/0	0/0	0/0	0/0	0/0	0/0

CF= control flank

TF= Test flank

M= Male

F= Female

Body weight (g)

animal n°	085/M	205/M	107/M
at start if test	2490	2260	2240
after 3 days (end)	2570	2330	2300

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is classified as non-irritant to the skin rabbit.

Executive summary:

The acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of the test substance on the albino rabbit skin.

This test was besed on the OECD Guideline N°.404, adopted May 12, 1981.

Under the experimental conditions employed, the test item, induced slight erythema reactions when applied to the albino rabbits skin.

The reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test item can be classified as non-irritant.