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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23/05/1989-26/05/1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Official method as defined by the decree of 1982, February the first (Journal officiel de la République Française de 1982, 21st February)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Lecithins, hydrogenated
EC Number:
295-786-7
EC Name:
Lecithins, hydrogenated
Cas Number:
92128-87-5
Molecular formula:
not applicable - UVCB substance
IUPAC Name:
Lecithins, hydrogenated
Specific details on test material used for the study:
Received on May the 3rd, 1989, a sample with the following characteristics :
Container : transparent glass flasks
Colour : light yellow
pH : 6.88
kept at room temperature for three years at most.

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
Not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0,5 ml of the undiluted test product was laid down on a square gauze which was immediately applied on the skin (normal and scarified) of three rabbits
Duration of treatment / exposure:
24h
Observation period:
48h
Number of animals:
3 (according to OECD 404, taking into account the category to which the product belongs)
Details on study design:
Not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 0
Max. score:
3
Reversibility:
fully reversible within: quickly
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
3
Reversibility:
fully reversible within: quickly
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible within: quickly
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
no assessment was performed at 48h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
no assessment was performed at 48h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
no assessment was performed at 48h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
no assessment was performed at 48h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
no assessment was performed at 48h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
no assessment was performed at 48h
Irritant / corrosive response data:
The results above are about tests on "normal skin".
IPC (Index of primary cutaneous irritation) = 0.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

According to the adopted classification, and under the experimental conditions of the test, the test product was NOT IRRITANT (IPe = 0.3) when applied undiluted on rabbit skin.

ln view of the results obtained and in the absence of any change in skin structure, the cutaneous tolerance of rabbit appeared EXCELLENT.