Fatty acids, C16-18, Me esters

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:

weight of evidence

Study period:

08 Jan - 12 Jan 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions; analytical purity of the test item was not given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., Me esters

EC Number:

267-015-4

EC Name:

Fatty acids, C16-18 and C18-unsatd., Me esters

Cas Number:

67762-38-3

Molecular formula:

UVCB substance, not univocal molecular formula available

IUPAC Name:

Methyl (9E,12E,15E)-octadeca-9,12,15-trienoate methyl (9Z)-octadec-9-enoate methyl (9Z,12Z)-octadeca-9,12-dienoate methyl hexadecanoate methyl octadecanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Substance type: Fatty acids, C16-18 & C18-unsaturated, methyl esters
- Physical state: liquid, yellow
- Analytical purity: not specified

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 15 months
- Weight at study initiation: approx. 2840 g
- Diet: Altromin-Haltungsdiät 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal skin, 6 cm²
- Type of wrap if used: air- and vapour permeable moisted gauze patch fixed with hypoallergenic adhesive gauze patch bandage.

REMOVAL OF TEST SUBSTANCE
- None

SCORING SYSTEM: according to the council directive 84/449/EEC, i.e., Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: erythema graded 1 was seen at reading time point 1 hour only.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: erythema graded 1 was seen at 1 and 24 h.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: erythema graded 1 was seen at 1, 24 and 48 h.

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

mean out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: none of the 3 animals showed edema at any time point considered.

Irritant / corrosive response data:

Slight erythema graded 1 was seen in all 3 animals at reading time point 1 hour and disappeared within 24 to 72 hours. None of the animals showed edema.

Any other information on results incl. tables

Table 1: Individual erythema scores at all reading time points:

Animal Number	1 h	24 h	48 h	72 h
1	1	0	0	0
2	1	1	0	0
3	1	1	1	0

 

Table 2: Individual edema scores at all reading time points:

Animal Number	1 h	24 h	48 h	72 h
1	0	0	0	0
2	0	0	0	0
3	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified