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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Amines, C12-18 (even numbered) -alkyldimethyl, N-oxides
IUPAC Name:
Amines, C12-18 (even numbered) -alkyldimethyl, N-oxides
Constituent 2
Reference substance name:
931-341-1
EC Number:
931-341-1
IUPAC Name:
931-341-1
Details on test material:
Name of test material: Hoe S 3406
Composition: 30 % AO in water, < 0.3 % free fatty alcohol, <0.5 % free amine, < 0.1 % hydrogen peroxide
Lot No. E 06201864

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: no data
- Weight at study initiation: 2.6-3.4 kg
- Housing:no data
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/- 10
- Air changes (per hr): air conditioned room, no data
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 % w/v

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage:
- Type of wrap if used: semi-occlusive binding, no further details

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no description of method
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48 & 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48 & 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48 & 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48 & 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The C12-18 AO is a skin irritant in this study.