Reaction mass of 3-({[2,2-dimethyl-3-({[2-(2-{[(prop-2-en-1-yloxy)carbonyl]oxy}ethoxy)ethoxy]carbonyl}oxy)propoxy]carbonyl}oxy)prop-1-ene and 3-{[(2,2-dimethyl-3-{[(prop-2-en-1-yloxy)carbonyl]oxy}propoxy)carbonyl]oxy}prop-1-ene and diallyl 2,2'-oxydiethyl dicarbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August- September 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The observation period should be up to 14 days after administration (in the present study the last observation was done at 72 hours after administration).

GLP compliance:

no

Remarks:

The sudy was performed prior to the adoption of the GLP compliance

Test material

Test material information

Constituent 1

Reference substance name:

Diallyl 2,2'-oxydiethyl dicarbonate

EC Number:

205-528-7

EC Name:

Diallyl 2,2'-oxydiethyl dicarbonate

Cas Number:

142-22-3

Molecular formula:

C12H18O7

IUPAC Name:

diallyl 2,2'-oxydiethyl dicarbonate

Details on test material:

- Substance type: organic
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: data not available
- Age at study initiation: data not available
- Weight at study initiation: data not available
- Housing:data not available
- Diet (e.g. ad libitum): data not available
- Water (e.g. ad libitum):data not available
- Acclimation period:data not available


ENVIRONMENTAL CONDITIONS
data not available

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one test site was abraded, the other one remained intact

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours after administration

Number of animals:

4

Details on study design:

The test procedure was modeled after that of Draize et al. Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit.

TEST SITE
- Area of exposure: Two test sites located lateral to the midline of the back approximately ten centimeters apart were selected.
- % coverage: no data

The test material was applied to each of the test sites on each rabbit.
- Type of wrap if used: The test sites were immediately occluded with two-inch square gauze patches. The patches were placed directly over the test sites and secured with masking tape. The trunk' of each animal was then wrapped with impervious plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the 24-hour exposure period. To prevent ingestion, a light-weight collar was placed on each animal.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24 hours

The intact and abraded test sites were examined and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours, the sites were reexamined and rescored. In evaluating the average irritation present, the mean scores for erythema and edema of the intact lest sites after 24 and 72 hours were added. Similarly, the mean scores for erythema and edema of the abraded test sites after 24 and 72 hours were added. These two values were totaled and divided by four to obtain the mean primary irritation score.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3.5

Time point:

other: 24 hours

Score:

2 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: abraded skin sites

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3.5

Time point:

other: 72 hours

Score:

2 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: abraded skin sites

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

3.5

Time point:

other: 24 hours

Score:

2 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: abraded skin sites

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

3.2

Time point:

other: 72 hours

Score:

1 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: abraded skin sites

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3.5

Time point:

other: 24 hours

Score:

2 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: intact skin sites

Results 6

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3.5

Time point:

other: 72 hours

Score:

2 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: intact skin sites

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

3.5

Time point:

other: 24 hours

Score:

2 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: intact skin sites

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

3.2

Time point:

other: 72 hours

Score:

1 - 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: intact skin sites

Irritant / corrosive response data:

no data

Other effects:

not known

Any other information on results incl. tables

Table 3: Results of Primary Skin Irritation Test (Report Date: 10 September 1971)

TEST MATERIAL: 'diallyl 2,2'oxydiethyl dicarbonate'
Primary Skin Irritation Test - Albino Rabbits
Results
Animal Number	Irritation Scores for Abraded Skin Sites At:				Irritation Scores for Intact Skin Sites At:
	24 Hours		72 Hours		24 Hours		72 Hours
	Er.	Ed.	Er.	Ed.	Er.	Ed.	Er.	Ed.
1	4	4*	4	4*	4	4*	4	4*
2	2	2	2	1	2	2	2	1
3	4	4**	4	4**	4	4**	4	4**
4	4	4**	4	4**	4	4**	4	4**
Mean	3.5	3. 5	3. 5	3. 2	3.5	3. 5	3. 5	3. 2
Subtotal	13. 7				13. 7
Primary Irritation Score = 6.8

Key: Er. = Erythema Ed, = Edema * Subdermal hemorrhage ** Superficial burns

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In 3/4 rabbits, both abraded and non-abraded sites had scores of 4 for both erythema and edema at 24 and 72 hours (beet or crimson red erythema and swelling of more than 1 mm). Superficial burns were noted in 2 of these animals at both time points. Erythema and edema were not as severe in one animal (scores of 2 and 1). The average primary irritation score was 6.8 (extremely irritating).

Executive summary:

Undiluted test material (0.5 mL) was applied to one intact and one abraded skin site on four rabbits under occluded conditions for 24 hours and assessed for up to 72 hours after exposure. In three of the four rabbits, both abraded and non-abraded sites showed severe erythema and edema at 24 and 72 hours. Carbonic acid, oxydiethylene diallyl ester was highly irritating to rabbit skin.