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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Jan - 29 Jan 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study. Lack of details on test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
lack of details on test material
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isooctadecanoic acid, monoester with glycerol
EC Number:
266-124-4
EC Name:
Isooctadecanoic acid, monoester with glycerol
Cas Number:
66085-00-5
Molecular formula:
C21H42O4
IUPAC Name:
1,3-Dihydroxy-2-propanyl 16-methylheptadecanoate
Details on test material:
- Name of test material (as cited in study report): [trade name] glycerol mono-isostearate
- Physical state: colourless liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage des Feuilletas, Campet Lamolere, France
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individually in stainless steel cages (61 x 46 x 34 cm) with grid floor. The door of each cage was equipped with a feeding device and a 1000 mL drinking bottle.
- Diet: UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite flank of the same animals was treated with dist. water
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
5 days
Reading time points: 1, 24, 48 and 72 h and 5 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: the test material was applied on a Codex hydrophilic eight layer gauze (2.5 x 2.5 cm) which was then laid down on the skin. The gauzes were kept in contact with the skin using a hypoallergenic microporous adhesive strip (50 mm wide) and held in place with a stretchable band wraped around the animal.

SCORING SYSTEM: Draize scoring system

OBSERVATIONS
Any behavioural disorder, any modification in the vegetative reactions or in feeding and drinking consumption of the animals were duly recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight erythema was observed in 2/3 animals at 1, 24 and 48 h post-application, no longer noted at the 72 h reading. In one of these animals, very slight edema was observed at the 1 h reading only.
Well-defined erythema was observed in the third animal at 1, 24 and 48 h post-application, becoming slight at 72 h, which vanished on Day 5. This animal showed very slight edema at 1, 24 and 48 h. No edema was noted at 72 h.
Slight changes in cutaneous structure were also observed, which showed to be slowly reversible.
Other effects:
No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time Rabbit no.
1 2 3
Erythema Edema Erythema Edema Erythema Edema
1 h 1 1 2 1 1 0
24 h 1 0 2 1 1 0
48 h 1 0 2 1 1 0
72 h 0 0 1 0 0 0
5 days 0 0 0 0 0 0
Mean value 24 + 48 + 72 h 0.67 0.00 1.67 0.67 0.67 0.00

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