Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
29 Jan - 04 Feb 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive dressing; no details on reading time points
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Commission Directive 84/449/EEC
Deviations:
yes
Remarks:
occlusive dressing; no details on reading time points
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Palmitic acid
EC Number:
200-312-9
EC Name:
Palmitic acid
Cas Number:
57-10-3
Molecular formula:
C16H32O2
IUPAC Name:
hexadecanoic acid

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb: HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, Kuchen, Germany
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20 - 21
- Humidity (%): approx. 45 - 50
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
4 males
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: The substance was applied to the intact skin using a patch (2.5x2.5 cm), which was covered by a plastic foil using adhesive plasters and an acrylastic band aid.

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3 and #4
Time point:
other: mean over all reading time points
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3 and #4
Time point:
other: mean over all reading time points
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal:
Remarks:
#1, #2, #3, #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
no details on reading time points given
Irritation parameter:
edema score
Basis:
animal:
Remarks:
#1, #2, #3, #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
no details on reading time points given
Irritant / corrosive response data:
No skin reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified