Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1984-03-26 To 1984-07-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a: The study was performed according to OECD guideline 404 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, vegetable-oil, Me esters
EC Number:
273-606-8
EC Name:
Fatty acids, vegetable-oil, Me esters
Cas Number:
68990-52-3
Molecular formula:
UVCB substance, not univocal molecular formula available
IUPAC Name:
UVCB substance, no IUPAC name avalilable, chemical name Fatty acids, vegetable-oil, Me esters The substance is syntetised by transesterification of natural obtained oils with methanol to produce methylesters and glycerin or esterification of fatty acids to produce methyl esters and water.
Details on test material:
- Name of test material : Metiloil A
- Physical state: yellow liquid
- Storage condition of test material: at room temperature
- Composition of test material, percentage of components: mixture of methylesthers of satured and insatured C16to 18 fatty acids, no data
- Lot/batch No.: 1169
- Acid number: 7 mgKOH/g

Test animals

Species:
rabbit
Strain:
other: New Zealand White: Hy/Cr
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Age at study initiation: no data
- Weight at study initiation: 2.35 kg +/- 0.05 kg
- Housing: individually in polystyrene cage (35 x 55 x 32 cm).
- Diet: rabbit diet SQC (Special diets Services Ltd, Witham, Essex, England), ad libitum
- Water: filtered water with 0.22 µm Millipore membrane (Millipore, 67120 Molsheim, France), ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 50 % +/- 20 %
- Air changes (per hr): no data (filtered Air)
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1984-05-18 To: 1984-05-21

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left flank
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 ml







Duration of treatment / exposure:
4 hours

Observation period:
3 days

Number of animals:
6

Details on study design:
TEST SITE
- Area of exposure: right flank (6 cm2)
- % coverage: no data
- Type of wrap if used: A gauze pad was applied on the tested area and was held in contact with the skin by means of an adhesive hypoallergenic
semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE: No

SCORING SYSTEM: according to the grading of skin reactions described in OECD guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
> 0 - < 0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight erythema was observed in all animals after one hour exposure and disappeared completely after 3 days. No edema was reported.
See table 1 in field "Remarks on results including tables and figures".
Other effects:
No other local or systemic effects were observed.

Any other information on results incl. tables

Table1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility  Erythema
Max. score: 4
Edema
Max. score: 4

60 min

2/2/2/2/2/2 0/0/0/0/0/0

24 h

0/1/0/1/0/0 0/0/0/0/0/0

48 h

0/0/0/0/0/0 0/0/0/0/0/0

72 h

0/0/0/0/0/0 0/0/0/0/0/0

Average 24h, 48h, 72h

0.33/0/0 0

Reversibility*)

c. -

*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible

Grading of skin reactions:

Erythema and Eschar Formation

0 = No erythema

1 = Very slight erythema (barely perceptible)

2 = Well defined erythema

3 = Moderate to severe erythema

4 = Severe erythema (beef redness) to eschar formation preventing grading of erythema

Edema Formation

0 = No edema

1 = Very slight edema (barely perceptible)

2 = Slight edema (edges of area well defined by definite raising)

3 = Moderate edema (raised approximately 1 mm)

4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Metiloil A was not considered to be a skin irritant.
Executive summary:

In a primary dermal irritation study (Kaysen A., 1984), young adult New Zealand White rabbits (6 males) were exposed by dermal contact to 0.5 ml of Metiloil A (batch No. 1169) onto one flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 3 days. Irritation was scored by the grading of skin reactions described in the OECD guideline 404. Slight erythema was observed in all animals after one hour exposure and disappeared completely after 3 days. No edema was observed. Mean scores over 1, 24, 48 and 72 hours were 2, 0.33, 0 and 0 for erythema and 0, 0, 0 and 0 for edema, respectivelly.

In this study, metiloil A is slightly irritating when applied topically to rabbit skin, but not classified according to the EU-GHS criteria.