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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
18 - 21 Apr 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on test substance purity, no experimental 48 h reading performed).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972
Reference Type:
secondary source
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
additional testing on abraded skin, no experimental 48 h reading performed
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan, (Z)-9-octadecenoate (2:3)
EC Number:
232-360-1
EC Name:
Sorbitan, (Z)-9-octadecenoate (2:3)
Cas Number:
8007-43-0
Molecular formula:
C42H76O7
IUPAC Name:
(1R)-1-[(2R,3R,4S)-4-hydroxy-3-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]-2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z)-octadec-9-enoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl (9Z)-octadec-9-enoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]ethyl (9Z)-octadec-9-enoate
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Physical state: clear yellow liquid
- Analytical purity: no data
- Lot/batch No.: 204

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h, reading time points 24 h and 72 h
Number of animals:
6 males (3 intact, 3 abraded)
Details on study design:
TEST SITE
- Area of exposure: 6.45 cm²
- Type of wrap if used: cloth

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals (intact skin)
Time point:
other: mean out of 24 and 72 h
Score:
1.89
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals (intact skin)
Time point:
other: mean out of 24 and 72 h
Score:
0.78
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).
Irritant / corrosive response data:
At 24 h slight to moderate erythema and slight edema was noted. At the 72 h readings well-defined erythema and very slight edema was noted.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified