Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7 odd-numbered alkyl) derivs. and sodium hydroxide and chloroacetic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Study in accordance with US FHSA/CPSC design, 16 CFR 1500 for Skin Irritation testing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA/CPSC Design, 16 CFR 1500 for Skin Irritation testing

Principles of method if other than guideline:

Occlusive 24h application of 0.5 mL of test item to unabraded and abraded skin sites of each rabbit and skin examination at 24 and 72h after application

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, chloro-, reaction products with 2-heptyl-4,5-dihydro-1H-imidazole-1-ethanol and sodium hydroxide

EC Number:

271-792-5

EC Name:

Acetic acid, chloro-, reaction products with 2-heptyl-4,5-dihydro-1H-imidazole-1-ethanol and sodium hydroxide

Cas Number:

68608-64-0

Test material form:

solid - liquid: aqueous solution

Details on test material:

Substance tested as different commercial products:
- Mackam 2CY-75, 15% solids (active + impurities) [batch L-48049] in Acute Oral Toxicity, Skin Irritation and Eye Irritation
- Miranol J2M Conc, 49% solids (typical) [batch 2902D77] in Acute Oral Toxicity, or [batch 4349D78] in Skin Irritation and Eye Irritation
- Miranol J2M Anhydrous Acid, 100% solids (assumed) [batch 5958D80] in Acute Oral Toxicity
- Miranol J2M Freeze Dried, 100% solids (measured) [batch R-0469-203-19] in Genetic Toxicity In Vitro

Specific details on test material used for the study:

Trade name: Mackam 2CY-75
Purity: 15% solids (active and impurities)
Chemical active ingredient: Disodium caprylo amphoacetate
CAS No.: 68608-64-0
Batch No.: L-48049

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: not specified
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature, humidity and light controlled rooms (no details provided)

IN-LIFE DATES: Not detailed

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL per site to unabraded and abraded skin sites

Duration of treatment / exposure:

24 hours

Observation period:

Skin reactions graded at 24 and 72 hours after application

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: approximately 1'' square
- % coverage: 100 (2-layer gauze patch secured with non-irritation porous adhesive tape)
- Type of wrap if used: entire site covered wth 4 mil plastic wrap and secured with more adhesive tape

REMOVAL OF TEST SUBSTANCE
- At the end of the 24-hour contact period, excess material was removed from the sites

OBSERVATION TIME POINTS
- 24 and 72 hours after application

SCORING SYSTEM:
- Method of calculation: Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 2

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 4

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 5

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 6

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 7

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 8

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 9

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 11

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 12

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 13

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 14

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 15

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 16

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 17

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 18

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 19

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 20

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 21

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 22

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 23

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Results 24

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Unabraded skin

Results 25

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24/72h

Score:

ca. 1

Max. score:

2

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

See details in Table below

Any other information on results incl. tables

Rabbit	Erythema/Eschar (unabraded skin)				Edema (unabraded skin)				Erythema/Eschar (abraded skin)				Edema (abraded skin)				Reversibility
	24h	48h	72h	Mean	24h	48h	72h	Mean	24h	48h	72h	Mean	24h	48h	72h	Mean
512	1	N/A	1	1.0	2	N/A	0	1.0	1	N/A	1	1.0	2	N/A	0	1.0	N/A
513	1	N/A	0	0.5	0	N/A	0	0.0	1	N/A	0	0.5	0	N/A	0	0.0	N/A
514	1	N/A	0	0.5	1	N/A	0	0.5	1	N/A	1	1.0	1	N/A	0	0.5	N/A
515	0	N/A	0	0.0	0	N/A	0	0.0	1	N/A	0	0.5	0	N/A	0	0.0	N/A
516	1	N/A	0	0.5	1	N/A	0	0.5	1	N/A	1	1.0	1	N/A	0	0.5	N/A
517	1	N/A	0	0.5	0	N/A	0	0.0	1	N/A	0	0.5	1	N/A	0	0.5	N/A
N/A Not assessed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not a skin irritant based on in vivo testing

Executive summary:

Disodium caprylo amphodiacetate, as Mackam 2CY-75, 15% solids, was tested for its skin irritation potential in New-Zealand White rabbits. The test article was applied as such at a dose of 0.5 mL to unabraded and abraded skin sites on a clipped area of each of 6 rabbits. The test sites were occluded and the test material remained on the skin for a 24-hour contact period. The application sites were graded for indications of skin reactions (erythema and/or edema) using the Draize Scoring System at 24 and 72 hours after sample application.

No significant skin reactions occurred over the observation period.

Under the conditions of the experiment, the primary dermal irritation score was 1.0, indicating that disodium caprylo amphoacetate, as Mackam 2CY-75, 15% solids, is not irritating to the skin.