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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
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.
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.
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.
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