N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec. 15, 2003 to Jan. 28, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 17, 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

457-280-6

EC Name:

-

Cas Number:

126803-19-8

Molecular formula:

C16H20F6NOSb

IUPAC Name:

λ⁵-antimony(5+) N-[(4-methoxyphenyl)methyl]-N,N-dimethylanilinium hexafluoride

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Corporate Toxicology

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test article was individually weighed and moistened with 0.3 ml of distilled water to form a paste.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: The animals were housed 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12 hour light/dark cycle

IN-LIFE DATES: From: Dec. 16, 2003 To: Ja. 2, 2004

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site, was approximately 10 x 10 cm and remained intact.

Vehicle:

water

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): The test article was individually weighed and moistened with 0.3 ml of distilled water to form a paste.

Duration of treatment / exposure:

3 min, 1 h, 4 h (Animal 1)
4 h (Animal 2 & 3))
The test article (0.5 g) was applied dermally to three intact sites for an exposure period of three minutes on site #1, one hour on site #2 and four hours on site #3.

Observation period:

Dermal reactions were scored at 60 minutes after each patch removal on all three sites. Site #3 was scored again at 24, 48 and 72 hours.

Number of animals:

3 (Animal 1 and Animal 3: males, Animal 2: female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: plastic (semi-occlusive)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: Animal 1 (male) - 3 min (site #1), 1h (site #2), 4h (site #3). Animal 2 (female) and Animal 3 (male) - 4h (site #3)

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
The test sites of all animals were scored for dermal irritation at 60 minutes after removal of wrappings. Site #3 was scored at 24, 48 and 72 hours.

SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Male, Site #1 - 3min exposure

Time point:

other: 1 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Male, Site #2 - 1h exposure

Time point:

other: 1 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Male, Site #3 - 4h exposure

Time point:

other: 1 h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Female, Site #3 - 4h exposure

Time point:

other: 1 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Male, Site #3 - 4h exposure

Time point:

other: 1 h

Score:

0

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Male, Site #3 - 4h exposure

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Female, Site #3 - 4h exposure

Time point:

24/48/72 h

Score:

0

Results 8

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Male, Site #3 - 4h exposure

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Male, Site #1 - 3min exposure

Time point:

other: 1 h

Score:

0

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Male, Site #2 - 1h exposure

Time point:

other: 1 h

Score:

0

Results 11

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Male, Site #3 - 1h exposure

Time point:

other: 1 h

Score:

0

Results 12

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Male, Site #3 - 4h exposure

Time point:

24/48/72 h

Score:

0

Results 13

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

Female, Site #3 - 4h exposure

Time point:

24/48/72 h

Score:

0

Results 14

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

Male, Site #3 - 4h exposure

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Dermal Observations (Table 1)
Initial animal- There was no erythema or edema noted-at any of the observation time periods.
Additional animals - There was no erythema or edema noted at any observation time period.

Other effects:

Systemic Observations (Table 1)
There were no abnormal physical signs noted during the observation period.
All body weight changes were normal.

Any other information on results incl. tables

Table 1: Dermal Observations, Body Weight and Systemic Observations
	Animal No	Animal 1	Animal 2	Animal 3
	Sex	M	F	M
	Pretest Body Weight - Kg	2.2	2.6	2.7
	Terminal Body Weight - Kg	2.5	2.6	2.7
Exposure time	Time after patch removal	Erythema & Escar Formation			Mean scores
Site #1 - 3 min	1h	0	N/A	N/A
Site #2 - 1h	1h	0	N/A	N/A
Site #3 - 4h	1h	0	0	0	0
Site #3 - 4h	24h	0	0	0	0
Site #3 - 4h	48h	0	0	0	0
Site #3 - 4h	72h	0	0	0	0
Exposure time	Time after patch removal	Edema			Mean scores
Site #1 - 3 min	1h	0	N/A	N/A
Site #2 - 1h	1h	0	N/A	N/A
Site #3 - 4h	1h	0	0	0	0
Site #3 - 4h	24h	0	0	0	0
Site #3 - 4h	48h	0	0	0	0
Site #3 - 4h	72h	0	0	0	0
		Sum of Mean Scores =			0
		Modified Primary Irritation Index(PII)= Sum of Mean Scores/2=			0
		Systemic observations
	1h	A	A	A
	24h	A	A	A
	48h	A	A	A
	72h	A	A	A
		A=Normal
		N/A = not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate is not a dermal irritant.

Executive summary:

There was no erythema or edema noted at any of the observation time periods in any animal.
There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

The Modified Primary Irritation Index for the test substance is 0 and thus it is not a dermal irritant.