C12-16-(even numbered)-alkyl-dimethylammonium lactate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

08/02/1988-07/04/1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance. It is hypothesized that the toxicity of the target chemical can be derived from the respective toxicity data of DMAs with comparable length of alkyl chain (source substances). The underlying scientific rationale is based on the physico-chemical property of the target chemical and “chain length category”.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

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:

Dodecyldimethylamine

EC Number:

203-943-8

EC Name:

Dodecyldimethylamine

Cas Number:

112-18-5

IUPAC Name:

N,N-dimethyldodecan-1-amine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-3.4 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITONS
- Temperature (°C): 20 +/- 3ºC
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours or 3 minutes

Observation period:

30-60 minutes, 24, 48 and 72 hours after end of exposure, and after 7 and 14 days

Number of animals:

four

Details on study design:

TEST SITE
- Area of exposure: 2,5 x 2,5 cm
- % coverage: 100%
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water
- Time after start of exposure: 3 min or 4 h

SCORING SYSTEM:
Erythema and eschar formation
No erythema: 0
Very slight erythem: 1
Well-defined erythema:2
Moderate to severe erythema: 3
Severe erythema to slight eschar formation: 4

Oedema formation
No oedema:0
Very slight oedema: 1
Slight oedema:2
Moderate oedema:3
Severe oedema:4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(4 h exposure)

Basis:

animal #1

Time point:

other: 30-60'

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of observation scar and eschar formation was visible

Results 2

Irritation parameter:

edema score

Remarks:

(4 h exposure)

Basis:

animal #1

Time point:

other: 30-60'

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

erythema score

Remarks:

(4 h exposure)

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

edema score

Remarks:

(4 h exposure)

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

erythema score

Remarks:

(3 min exposure)

Basis:

animal: #2, #3, #4

Time point:

other: 30-60'

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of observation scar and schar fomation wee vivible

Results 6

Irritation parameter:

edema score

Remarks:

(3 min exposure)

Basis:

animal: #2, #3, #4

Time point:

other: 30-60'

Score:

0

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of observation scar and eschar formation was visible

Results 7

Irritation parameter:

erythema score

Remarks:

(3 min exposure)

Basis:

animal #2

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of observation eschar formation were visible

Results 8

Irritation parameter:

erythema score

Remarks:

(3 min exposure)

Basis:

animal #3

Time point:

other: 24, 48 and 72 h

Score:

1.33

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of observation eschar formation were visible

Results 9

Irritation parameter:

erythema score

Remarks:

(3 min exposure)

Basis:

animal #4

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of observation flaked skin was visible, as well as scar and eschar formation

Results 10

Irritation parameter:

edema score

Remarks:

( 3 min exposure)

Basis:

animal: #2, #3

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

edema score

Remarks:

(3 min exposure)

Basis:

animal #4

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

4 h exposure: 1-72 h after the end of exposure the application site was swollen, surrounded by a well-definded moderate erythema
After 7 days the edema was not evaluable due to hardening, surrounded by a severe erythema. 24 h post exposure the treated area revealed a brownish discolouration, was arched upwards, encrusted and scabbed.
3 min exposure: 24 to 72 h post exposure the animals revealed hardly perceptible to moderate erythema, 2 of 3 animals with slight edema. From 7 to 14 days the skin of 2 animals showed hardening, surrounded by hardly perceptible to moderate erythema and slight to severe edema. This was accompanied by yellowish or light brown discolouration dryness and eschar formation. The skin was scabby, arched upwards, parchmenty, fissured and crusty. One animal recovered completely, another animal had a definite scar.

Any other information on results incl. tables

4 hours
time	30-60 '	24h	48h	72h	7 d
animal number	1	1	1		1
Erythema	2	3*	3*	2*	4*
Oedema	4	4	4	4	+

* Erythema assessment due to the patch body staining only assessable

+Swelling due to hardening of not evaluable

3 minutes
time	30-60 '			24h			48h			72h			7 d			14 d
animal number	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Erythema	1	1	1	1	2	1	1	1	2	1	1	3	3*	2*	1	3*	2*	0
Oedema	0	0	0	2	2	0	2	2	0	2	2	0	2*	2*	0	4*	3*	0

* Assessment only to the hardening

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The skin irritation/corrosion of the target substance was assessed based on the analogue approach using N,N-dimethyldodecan-1-amine as read-across supporting substance. According to the current investigations, the substance N,N-dimethyldodecan-1-amine is corrosive to the skin of rabbits.

Executive summary:

The skin irritation/corrosion of the target substance was assessed based on the analogue approach using N,N-dimethyldodecan-1-amine as read-across supporting substance.

New Zealand rabbits were treated with the test substance in an dermal irritation/corrosion study according to guidelines OECD 404 and EU B.4. 3 min of exposure produced erythema and edema scores of 1, 1.33 and 2 (erythema) and 2, 2 and 0 (edema) respectively.

This was accompanied by yellowish or light brown discolouration dryness and eschar and scar formation. The skin was scabby, arched upwards, parchmenty, fissured and crusty. One animal recovered completely, another animal had a definite scar.

After 4 hours the skin of this animal was also destructed and scar was formed. After 3 minutes in 1 animal scars were formed. The test substance is corrosive to rabbit skin.