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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Different studies (SIDS, 2006) indicate that Amine Oxides:   

  • were not irritating to the skin and eye at low concentrations (1%),
  • were moderately irritating at 5%,
  • more severely irritating when tested as produced (e.g., ~30% aqueous solutions). 
  • and there is no need to test the pure compound for irritation since it is not available in that form and the consumer will never be exposed to this concentration.

Concerning the N,N-Dimethyl-1-octadecanamine-N-oxide, two studies are available:

one for skin irritation : the substance at a concentration of 2

  • .5%, is not irritating to the skin.
  • one for eye irritation : the substance at a concentration of 2.5% is not irritating to the skin.

In conclusion, the behaviour of the substance is in the scope of Amine Oxide category and the global conclusion of the SIDS report can be used.

N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) is considered as Skin Irritant H315 and Eye Irritant H319.

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Draize method
Principles of method if other than guideline:
Four skin lotions, containing 2.5% C18 Amine Oxide (CAS No. 2571-88-2), were tested for skin irritation in rabbits according to the Draize method. The objective is to compare the skin irritation score between skin lotion containing mineral oil or isopropyl palmitate.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: skin lotion
Controls:
not specified
Amount / concentration applied:
2.5%
Duration of treatment / exposure:
72 hours
Observation period:
14 days
Number of animals:
1-3
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
Lotion 1 (mineral oil, no quat)
Basis:
mean
Time point:
72 h
Score:
ca. 4
Reversibility:
not specified
Remarks on result:
other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
Lotion 2 (mineral oil, quat)
Basis:
mean
Time point:
72 h
Score:
ca. 6
Reversibility:
not specified
Remarks on result:
other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
Lotion 3 (isopropyl palmitate, no quat)
Basis:
mean
Time point:
72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
Lotion 4 (isopropyl palmitate, quat)
Basis:
mean
Time point:
72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions
Interpretation of results:
study cannot be used for classification
Conclusions:
N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) was evaluated for primary skin irritation in rabbits. The authors demonstrated the minimal to moderate skin irritation observed with two of the four formulas was due to the presence of 35% mineral oil with a single variable substitution with 35% isopropyl palmitate. All of the skin lotions contained 2.5% C18 AO, only those with mineral oil were skin irritants.
Executive summary:
N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) was evaluated for primary skin irritation in rabbits. The authors demonstrated the minimal to moderate skin irritation observed with two of the four formulas was due to the presence of 35% mineral oil with a single variable substitution with 35% isopropyl palmitate. All of the skin lotions contained 2.5% C18 AO, only those with mineral oil were skin irritants.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
other: skin lotion
Controls:
not specified
Amount / concentration applied:
Not specified
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
Not specified
Number of animals or in vitro replicates:
1-3
Details on study design:
For rabbits with washed eye treatment, washing occurred 4 seconds after application
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
No irritation was observed in rabbits with washed or unwashed eyes
Interpretation of results:
study cannot be used for classification
Conclusions:
N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) was evaluated for eye irritation in the rabbit according to the Draize method. Four skin lotions containing 2.5% C18 Amine Oxide were tested and shown to be non irritating.
Executive summary:

N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) was evaluated for eye irritation in the rabbit according to the Draize method. Four skin lotions containing 2.5% C18 Amine Oxide were tested and shown to be non irritating.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

As indicated in the read-across justification, data from Amine oxide can be used for read-across to N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5).

For skin and eye irritation, two studies on N,N-Dimethyl-1-octadecanamine-N-oxide has been used with a read-across justification in supporting study.

N,N-Dimethyl-1-octadecanamine-N-oxide is considered as Skin and Eye Irritant, H315, H319.