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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 - 12 Sep 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin irritation potential of the test substance was investigated in 3 rabbits. Individual scores were determined at 24 and 72 h according to Draize.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Onium compounds, morpholinium, 4-ethyl-4-soya alkyl, Et sulfates
EC Number:
263-167-0
EC Name:
Onium compounds, morpholinium, 4-ethyl-4-soya alkyl, Et sulfates
Cas Number:
61791-34-2
Molecular formula:
Not available for UVCB substance
IUPAC Name:
4-ethyl-4-(hexadecanoyloxy)morpholin-4-ium 4-ethyl-4-[(9E)-octadec-9-enoyloxy]morpholin-4-ium 4-ethyl-4-[(9E,12E)-octadeca-9,12-dienoyloxy]morpholin-4-ium triethyl sulfate

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Observation period:
24 and 72 h
Number of animals:
3 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
3.9
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
At the 24-h reading time point, two skin areas exhibited necrosis at the site of application of the test material. The remaining rabbits showed moderate erythema, whereof one also had a slight edema. At the 72-h reading time point, all rabbits showed necrotic skin areas. Besides the necrosis, edema were observed.

Any other information on results incl. tables

Table 1: Results of skin irritation study

Observation time Rabbit no.
1 2 3
Erythema Edema Erythema Edema Erythema Edema
24 h 3 1 4 0 4 0
48 h No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 72 h (worst case assumption)
72 h 4 2 4 2 4 3

Table 2: Calculation of mean scores

  Rabbit no.
1 2 3
Erythema Edema Erythema Edema Erythema Edema
Mean value 24 + 48 + 72 h* 3,666666667 1,666666667 4 1,333333333 4 2

Applicant's summary and conclusion

Interpretation of results:
other: Skin Corr. 1, H314 according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: Skin Corr. 1, H314

Based on the results of this study, irreversible effects (i.e. necrosis) were observed in all rabbits. Based on a worst case assumption, the mean scores (24/48/72 h) for erythema and edema were 3.9 and 1.6, respectively. Therefore the substance is classified as corrosive to the skin according to Regulation (EC) No. 1272/2008.