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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
investigation took place prior to introduction of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexadecyl acetate
EC Number:
211-103-7
EC Name:
Hexadecyl acetate
Cas Number:
629-70-9
Molecular formula:
C18H36O2
IUPAC Name:
hexadecyl acetate
Details on test material:
- Name of test material (as cited in study report): Acetulan
- Physical state: Cream coloured wax-like material
- Analytical purity: Declared by owner of study report to contain 90 % test item and to be equivalent to the substance described elsewhere in this dossier
- Lot/batch No.: 731

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
- The investigation was conducted on six adult albino rabbits selected from healthy, acclimated, animals.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL or 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
Six
Details on study design:
- The back of each animal was shaved free of hair.
- Intact skin was exposed on the left half of the shaved area.
- The right side of the shaved area was abraded.
- Test material (0.5 mL or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch.
- Patches were removed after 24 hours and observations recorded.
- Further observations were made after 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 24 h
Score:
1.17
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 72 h
Score:
1.33
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 24 h
Score:
1.17
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 72 h
Score:
1.33
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 24 h
Score:
0.17
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals 1 to 6
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
- Scoring of the effects produced by the test material is shown in Table 1 (attached).
- The test material produced erythema in all six animals with intact and abraded skin.
- The test material produced edema in one animal with abraded skin only.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the data presented, the test sample was considered to be a mild irritant to rabbit skin. Nevertheless, the scores for erythema and edema did not fall within the range requiring classification under the terms of Regulation (EC) No. 1272/2008 for 5 out of 6 animals over a period of 72 hours.
Executive summary:

METHOD

 

Acute skin irritation was investigated in the rabbit using a mixture declared to contain 90 % of test item.

RESULTS

The test material produced erythema in all six animals with intact and abraded skin. However, the test material produced edema in one animal with abraded skin only.

CONCLUSION

On the basis of the data presented, the test sample was considered to be a mild irritant to rabbit skin. Nevertheless, the scores for erythema and edema did not fall within the range requiring classification under the terms of Regulation (EC) No. 1272/2008 for 5 out of 6 animals over a period of 72 hours.