Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to OECD guidance 404 and to GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
EC Number:
271-653-9
EC Name:
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
Cas Number:
68603-38-3
IUPAC Name:
68603-38-3
Details on test material:
CAS name: Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
Four hours
Observation period:
Seven days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48/72 h (mean)
Score:
ca. 1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48/72 h (mean)
Score:
ca. 1.33
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/48/72 h (mean)
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/48/72 h (mean)
Score:
ca. 1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/48/72 h (mean)
Score:
ca. 1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/48/72 h (mean)
Score:
ca. 1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
On the basis of the mean scores (24/48/72 h) for erythema and edema, which were >=1.5 - <2.3 and fully reversible within 14 days, it is concluded that the test item causes mild skin irritation. This leads to the Category 3 according to GHS.
Executive summary:

A study according to the OECD guideline 404 and considering the GLP principles was carried out with the test item "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)" (CAS 68603 -38 -3). The dorsal fur of three male rabbits was shaved. After 24 hours, 0.5 g of the undiluted test substance was applied for 4 hours to the shaved skin area using a semi-occlusive cover. The reactions on skin were reported 24 / 48 / 72 hours and 7 / 14 days after treatment. All observed reactions disappeared within 14 days. On the basis of the mean scores (24/48/72 h) for erythema and edema, which were >=1.5 - <2.3, it is concluded that the test item causes mild skin irritation.