Ethyl cyanoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP lab testing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl cyanoacetate

EC Number:

203-309-0

EC Name:

Ethyl cyanoacetate

Cas Number:

105-56-6

Molecular formula:

C5H7NO2

IUPAC Name:

ethyl 2-cyanoacetate

Details on test material:

Purity: 99.7% , Apperance: Clear liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

They were in the weight range of 2.9 to 4.0 kg and approximate! y 13 to 19 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment. The rabbits were selected without conscious bias for the study. They were housed individually in metal cages with perforated floors in Building R 14 Room 5.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum. The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms.
Animal room temperature was maintained at approximately 19℃ and relative humidity at 30 - 70%. These environmental parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and I ighting was controlled by means of a time switch to give 12 hours of artificial I ight (0700 - 1900 hours) in each 24 hours period.

Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage was identified by a coloured label displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 ml amount of the test substance was applied under 25 mm * 25mm gauze pads.

Duration of treatment / exposure:

4 hours.

Observation period:

24h, 48h, 72h.

Number of animals:

3

Details on study design:

Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of
each rabbit exposing an area of skin approximately 100 mm x 100 mm.
A 0.5 ml amount of the test substance was applied under 25 mm x 25 mm gauze pads to three intact skin sites on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing.The first patch was removed after three minutes, the second patch after 60 minutes and the third after four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
Following removal of the patches the treatment sites were washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
One animal was treated one day in advance of the other two.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h

Score:

0

Reversibility:

other: no irritation occurs

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24h, 48h, 72h

Score:

0

Reversibility:

other: no irritation occurs

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24h, 48h, 72h

Score:

0

Reversibility:

other: no irritation occurs

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h

Score:

0

Reversibility:

other: no irritation occurs

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24h, 48h, 72h

Score:

0

Reversibility:

other: no irritation occurs

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24h, 48h, 72h

Score:

0

Reversibility:

other: no irritation occurs

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no signs of toxicity or ill health in any rabbit during the observation period.
No dermal response to treatment was observed in any animal following the 3 or 60 minute exposure. Transient very slight erythema was seen in one animal following the four hours exposure.