Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 June 1993 to 23 June 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EC B.4

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)

EC Number:

412-780-3

EC Name:

Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)

Cas Number:

1380226-46-9

Molecular formula:

A complex mixture of species so no unique molecular formula can be given

IUPAC Name:

dimolybdenum(6+) diammonium 2-{2-[(octadec-9-en-1-yl)amino]ethoxy}ethan-1-ol heptaoxidandiide

Test material form:

liquid: viscous

Details on test material:

- Name of test material: Additiv 104-Konzentrat
- Description: Dark red liquid
- Purity: Product by process; treated as 100% pure
- Lot/batch No.: DS 147
- Expiration date of the lot/batch: March 9, 1994
- Storage condition of test material: room temperature in the dark
- Stability under storage conditions and up to 60 degrees C: stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx. 12-13 weeks
- Weight at study initiation: 2385-2591 grams
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK—20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): relative humidity of 55%
- Air changes (per hr): Air-conditioned with 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

None

Amount / concentration applied:

0.5 gram

Duration of treatment / exposure:

4 hours

Observation period:

- Skin reactions: assessed at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days afterthe removal of the dressings and test substance.
- Viability/mortality/toxicity- assessed twice daily throughout duration of study.
- Bodyweight was recoreded on day of treatment (prior to application)

Number of animals:

3 male rabbits

Details on study design:

TEST SITE:
Approximately 24 hours before treatnent, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2). Prior to test substance administration, the animals were physically examined and the shaved area of skin to be treated wasnormal. On test day 1, 0.5 gram of the test substance was applied to the intact skin of the shaved area on one flank, using a Scotchpak-non-woven patch (2x3 cm, 3M, St.Paul, U.S.A.) mounted on Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test substance) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).

REMOVAL OF TEST SUBSTANCE:
Four hours after the application of the test substance, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue.

SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) - 4
OEDEMA FORMATION
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area well defined by definite raising) - 2
Moderate oedema (raised approximately 1 rum) - 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.7

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.7

Results 4

Irritation parameter:

erythema score

Max. score:

4

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: 1 (related to all animals)

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

2.3

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

3

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

3

Results 8

Irritation parameter:

edema score

Max. score:

3

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: 1 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes not fully reversible within 21 days

Other effects:

Erythema was difficult to score, due to brown staining of the treated skin in all animals, caused by the test substance

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance resulted in a primary irritation index of 4.5 (moderately irritating) when applied to the intact rabbit skin.

Executive summary:

In a GLP compliant, guideline Acute Toxicity: Dermal Irritation/Corrosion test the test substance resulted in a primary irritation index of 4.5 (moderately irritating) when applied to the intact rabbit skin.