Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
08/02/1988-07/04/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to the OECD Guideline 404 and it is GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecyldimethylamine
EC Number:
203-943-8
EC Name:
Dodecyldimethylamine
Cas Number:
112-18-5
Molecular formula:
C14H31N
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

Resultsopen allclose all
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
Irritation parameter:
edema score
Remarks:
(4 h exposure)
Basis:
animal #1
Time point:
other: 30-60'
Score:
4
Max. score:
4
Reversibility:
not reversible
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
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
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
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
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
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
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
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
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:
According to the current investigations, the substance is corrosive to the skin of rabbits.
Executive summary:

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.