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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
29 Jan - 04 Feb 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
application under occlusion; 4 animals used;
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:
palmitic acid
Details on test material:
- Name of test material (as cited in study report): Edenor C16
- Physical state: white powder
- Analytical purity: no data

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/D.
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, 7343, Kuchen, D
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, 4902 Bad Salzuflen; ad libitum
- Water: ad libitum tap water
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): ca. 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(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days; since no scores could be observed within 3 days the experiment was cancelled due to animal welfare reasons; therefore the short observation period of 3 days does not represent a deviation to the OECD Guideline 404)
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: ~2.5 x 2.5 cm
- Type of wrap if used: plastic foil with adhesive plasters and an acrylastic band aid

SCORING SYSTEM: Skin irritation/corrosion was evaluated according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 4 animals
Time point:
other: mean over all reading time points
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no effects
Irritation parameter:
edema score
Basis:
animal: out of all 4 animals
Time point:
other: mean over all reading time points
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no effects
Irritant / corrosive response data:
No skin reactions were observed.

Applicant's summary and conclusion

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