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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1989

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:
Iso Stearyl Alcohol
IUPAC Name:
Iso Stearyl Alcohol
Constituent 2
Chemical structure
Reference substance name:
Isooctadecan-1-ol
EC Number:
248-470-8
EC Name:
Isooctadecan-1-ol
Cas Number:
27458-93-1
Molecular formula:
C18H38O
IUPAC Name:
2-methylheptadecan-1-ol
Test material form:
other: Liquid
Details on test material:
Priosrine 3515 (> 99% purity)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
Post treatment - ca 1 hour, 24, 48 and 72 hours and 7 and 14 days
Number of animals:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
4
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
3
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
4
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 and 72 hours
Score:
4
Max. score:
4

Any other information on results incl. tables

The administration of Prisorine 3515 to intact rabbit skin resulted in a primary irritation index of 3.7 (moderately irritating) with very slight erythema and oedema in one of the test animals and moderate erythema and severe oedema in the other two animals (one of which also had eschar formation). The irritation was fully reversible within 14 days.

There was no other symptoms of toxicity or mortalilty during the study.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a well conducted study (OECD 404, GLP), the administration of Prisorine 3515 in a semi occlusive manner to the shaved skin of three albino rabbits for a period of four hours, resulted in a primary irritation index of 3.7 (moderately irritating).All effects were reversible after 14 days. Under the CLP Regulation (1272/2008) this would give rise to a classification of Category 2: Irritant.