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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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
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.