Quaternary ammonium compounds, N-(C16-18 and C18-unsatd. alkyl)-N,N,N',N',N'-pentamethyltrimethylenedi-, dichlorides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Nov - 25 Nov 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: No full product composition given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

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:

N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride

EC Number:

629-716-7

Cas Number:

1211950-04-7

Molecular formula:

No molecular formula

IUPAC Name:

N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride

Test material form:

liquid

Details on test material:

- Chemical name : N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride
- EC number : 629-716-7

“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animals: One male New Zealand White rabbit was used.
Acclimation: at least 5 days before the beginning of the study.
Weight: on the day of treatment, the animal had a body weight 2.5 kg.
Identification: individual metal ear tag.
Environmental conditions: under continuous control and recording.
. temperature: 18±3°C
. relative humidity: 30 to 70%
. lightldark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The animal was housed individually in polystyrene cage (48.2 cm x 58 cm x 36.5 cm).
The cage was equipped with a food container and a water bottle.
During the study, the animal had free access to 112 C pelleted diet (UAR, 91360 Villemoissonsur-Orge, France).
Each batch of food is analysed by the supplier for composition and contaminant levels. (appendix to report)
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories.

DEVIATION FORM PROTOCOL:
. the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol.
This minor deviation was not considered to compromise the validity or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped using electric clippers

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml placed on a dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animal. The pad was held in place by adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

Duration of treatment / exposure:

3 minutes and 4 hours
After removal of the dressing, any residual test substance was wiped off by means of a moistened gauze pad.

Observation period:

1 hour, 24, 48 and 72 hours after removal of the dressing.
When there was persistent cutaneous irritation after 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversibility.

Number of animals:

1

Details on study design:

The untreated skin served as control.
Any change in the animal's behaviour was noted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

3 minute exposure

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

Score 4 on day 8 when killed for ethical reason.

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

3 minute exposure

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

Score 4 on day 8 when killed for ethical reason.

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

4 hr exposure

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

Score 4 on day 8 when killed for ethical reason.

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

4 hr exposure

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

Score 4 on day 8 when killed for ethical reason.

Irritant / corrosive response data:

After a 3-minute or 4-hour exposure, a moderate to severe erythema (grade 3 or 4) and a slight to severe oedema (grade 2 or 4) were observed between day 2 and day 8; crusts were recorded from day 3 or day 5 and cutaneous necrosis was noted on day 8. The animal was then killed on day 8 for ethical reason.
Mean scores over 24, 48 and 72 hours for the animal after a 4-hour exposure were 3.0 for erythema and 2.0 for oedema.

Other effects:

no data.

Any other information on results incl. tables

Scoring dermal irritation:

			1h	24h	48h	72h	Mean
	rabbit	day	1	2	3	4	24/48/72	5	6	7	8
3 min	#1	Erythema	2	3	3	3	3,0	4	4	4	4
		Oedema	0	2	2	2	2,0	2	2	2	4
		Other
4-hrs	#1	Erythema	2	3	3	3	3,0	4	4	4	4
		Oedema	2	2	2	2	2,0	2	2	2	4
		Other			A	A		A	A	A	N

A = Crust

N = Necrosis

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Signs of necrosis became apparent after 8 days observation following 3 minutes exposure.
Therefore, the test substance STABIRAM MS6 is corrosive when applied topically to rabbits. GHS Cat. 1B.

Executive summary:

Stabiram MS6 was tested under GLP according to OECD 404.

0.5 ml was dermally applied to the clipped skin of one rabbits under semi-occusive conditions for 3 minutes and 4 hours. Following both exposure durations the mean score for erythema and edema at 24, 48 and 72 hours after patch removal were 3.0 for erythema and 2.0 for edema. Also following both exposures necrosis was noted on day 8.

Therefore Stabiram MS6 should be classified according to GHS as: Corrosive (Category 1B).