Quaternary ammonium compounds, di-C8-10-alkyldimethyl, chlorides

Skin irritation / corrosion

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5th january 1995 - 19th January 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.48 - 2.66 kg
- Housing: metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days (minimum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 19°C
- Humidity (%): 43 - 65%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL.

Duration of treatment / exposure:

3 minutes.

Observation period:

72 hours.

Number of animals:

3 animals

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: Total

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

other: Total

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Very slight erythma was noted at one treated skin site at 1 hour post-exposure and at two sites at the 24 hours post-exposure. Well defined erythma was noted at one exposed skin site at the 24 hours observation and two exposed skin sites at the 48 and 72 hour observation points. Desquamation or crust formation was noted at the 7 day obervation point. Crust formation was noted at one exposed skin site at the 14 day observation period.

Other effects:

Desquamation or crust formation was also noted at the 7-day observation point.

Any other information on results incl. tables

Individual Scores - Rabbit Number and Sex
Skin Reaction	Observation Time	41 Female	50 Male	52 Female	Total
Erythma/Eschar Formation	1 Hour	1	0	0	1
	24 Hours	2	1	1	4
	48 Hours	2	2	0	4
	72 Hours	2	2	0	4
	7 Days	1Cf	0Cf	0D	1
	14 Days	0Cf	0	0	0
Oedema Formation	1 Hour	0	0	0	0
	24 Hours	1	1	0	2
	48 Hours	1	1	0	2
	72 Hours	2	2	0	4
	7 Days	0	0	0	0
	14 Days	0	0	0	0

Cf: = crust formation       D = desquamation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The substance is considered to be a skin irritant following a 3 minute exposure period.

Executive summary:

In an in vivo skin irritation study New Zealand White rabbits were administered dermally with the unchanged substance for 3-minutes. The animals were then observed at 1 hour, 24 hours, 48 hours, 72 hours, 7 days and 14 days post-exposure for any adverse effects including signs of erythma and oedema. Very slight erythma was noted at one treated skin site at 1-hour post-exposure and at two sites at 24 hours post-exposure. Well defined erythma was noted at one exposed skin site at the 24-hour observation and two exposed skin sites at the 48 and 72 hour observation points. Desquamation or crust formation was noted at the 7-day observation point. Crust formation was noted at one exposed skin site at the 14-day observation period. Resultantly, the substance is considered to be a skin irritant following a 3-minute exposure period.