(ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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)

Version / remarks:

first version of 1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised

EC Number:

402-370-2

EC Name:

(ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised

Cas Number:

149057-70-5

Molecular formula:

C14H28AlNO6

IUPAC Name:

octaaluminium(3+) octakis((2Z)-4-ethoxy-4-oxobut-2-en-2-olate) octakis(1-methoxypropan-2-olate) octakis(2-(dimethylamino)ethan-1-olate)

Details on test material:

purity not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

3

Details on study design:

Approximately twenty-four hours prior to the commencement of the test, each of a group of three rabbits was prepared by closely clipping the fur from the dorsal/flank areas using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study. On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and. placed in position on the shorn skin. The patch was secured in position over the test material with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP). The animals were then returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.667

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

No adverse dermal reactions were noted one hour after removal of the wrappings. Very slight erythema was noted at two treatment sites at the 24, 48 and 72-hour observations. The remaining treated skin site showed no evidence of erythema or oedema during this period.

Desquamation was noted at one treatment site at the 24-hour observation and at all treatment sites at subsequent 48 and 72-hour observations.

Other effects:

Adverse dermal reactions on day seven were confined to desquamation at two treatment sites.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material A1/1/0 was found to be non-irritant to 3 rabbit skin in an OECD 404 test.

Executive summary:

The pure test material A1/1/0 was found to be non-irritant to 3 rabbit skin in an OECD 404 test.