Registration Dossier

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:
1987-04-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented OECD 404 study.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
Justification for the read-across from the introduced read-across supporting substance (CAS 67938 -21 -0) to the registration substance:
The introduced read-across supporting substance (CAS 67938-21-0) is structurally related to the registration substance. Both substances are fatty acid esters of polyglycerols, the only diffence being that the introduced read-across source substance (CAS 67938-21-0) is synthesized by using isostearic acid as fatty acid while the registration substance by using stearic acid.
Both substances are expected to undergo enzymatic hydrolysis resulting into the release of polyglyerols and the corresponding fatty acids (isostearic acid for the read-across supporting substance and the stearic acid for the registration substance. Isostearic acid as well as the stearic acid are well-investigated substances and occurs also endogenously. No significant difference in the skin irritation property can be derived.
Reason / purpose for cross-reference:
assessment report
Interpretation of results:
GHS criteria not met
Executive summary:

No classification is warranted for the registration substance based on the read-across data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Di(isooctadecanoic) acid, diester with oxydi(propanediol)
EC Number:
267-821-6
EC Name:
Di(isooctadecanoic) acid, diester with oxydi(propanediol)
Cas Number:
67938-21-0
Molecular formula:
C42H82O7
IUPAC Name:
di(isooctadecanoic) acid, diester with oxydi(propanediol)
Constituent 2
Reference substance name:
Diglyceryl-diisostearate
IUPAC Name:
Diglyceryl-diisostearate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Synonyms: Diglycerinisostearat, Polyglycerinisostearat
- Physical state: liquid
- Analytical purity: n.a.
- Composition of test material, percentage of components: 100 % Diglycerinisostearat
- Purity test date: n.a.
- Lot/batch No.: n.a.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 hours after removal of patch
Number of animals:
3
Details on study design:
Hostacerin DGI was tested for primary skin irritation according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL undiluted Hostacerin DGI. The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of skin took place after 30-60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0.1
Max. score:
2
Reversibility:
fully reversible
Remarks:
48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Irritant / corrosive response data:
24 hours after removal of the patches one animal exhibited a well defined erythema, whereas the other two animals showed no signs of irritation at all. From 48 hours after removal of the patches all animals were free of skin reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, technical grade of test item is not irritationg to the skin and thus not subject to labeling requirements.
Executive summary:

The test substance was tested for primary skin irritation according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL undiluted test substance. The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of skin took place after 30-60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of Draize.

24 hours after removal of the patches one animal exhibited a well defined erythema, whereas the other two animals showed no signs of irritation at all. From 48 hours after removal of the patches all animals were free of skin reactions.