Fatty acids, C16-18

Skin irritation / corrosion

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 guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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