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

Endpoint summary

Description of key information

In a reliable in vivo skin irritation study New Zealand White rabbits were administered dermally with a structurally similar substance (unchanged) 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 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. Resultantly, the substance is considered to be a skin irritant following a 3 minute exposure period.

In a reliable study, a single rabbit was administered a structurally similar substance (0.1 mL) in one eye. The substance was found to be extremely corrosive and the study was terminated by 1 hour following administration. The results show that the test material is corrosive to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3rd June 1991 - 18th June 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Only 1 animal was employed for testing and the animal was maintained for 1 hour only due to the severity of the reaction.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

1 second exposure followed by observations at 1, 24, 48 and 72 hours.

Observation period (in vivo):

1, 24, 48 and 72 hours.

Number of animals or in vitro replicates:

1 animal.

Other effects / acceptance of results:

The substance was very corrosive and the animal was sacrificed after 1 hour.

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 1 hour

Score:

94

Max. score:

94

Reversibility:

not reversible

Remarks on result:

not determinable

Remarks:

Due to excessive corrosivity.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance was corrosive as noted within an hour of substance administration to a single animal eye.

Executive summary:

A single rabbit was administered the test substance (0.1 mL) in one eye. The substance was found to be extremely corrosive and the study was terminated by 1 hour following administration. The results shows that the test material is corrosive to the eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on reliable skin and eye irritation studies on a structurally similar substance, as well as unreliable studies on the substance itself, the substance is classified as corrosive to the skin (Skin Corr. 1B, H314).