Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May 1986 - 11 Jun 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pripol 1017
- Physical state: viscous liquid
- Analytical purity: no data
- Composition of test material, percentage of components: Fatty acid, C18-unsatd., dimers 79 %, trimer 19 %, monomer 2 %
- Storage condition of test material: at ambient temperature in the dark
- Other: yellow

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute
- Age at study initiation: 12 to 14 weeks old
- Weight at study initiation: 2-3 kg
- Housing: individually housed in plastic cages with perforated floors
- Diet: standard laboratory animal diet restricted to 100 g per day
- Water (ad libitum): tap water
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.5
- Humidity (%): 60-70
- 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: untreated sites of the same animal served as control
Amount / concentration applied:
0.5 ml of test article was dosed as such
Duration of treatment / exposure:
4 hours
Observation period:
14 days; reading time points: 1, 24, 48, 72 hours and 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: one day before dose administration, the fur was removed from the central back of the animals by clipping, exposing an area of the skin of approx. 10 cm x 10 cm. Test article was applied to a 6 cm2 gauze patch, which was attached with a drop of petrolatum to aluminium foil and mounted on permeable tape. This was applied to one of the flanks of each animal, the other flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage.


REMOVAL OF TEST SUBSTANCE
After exposure the remaining test substance was removed, using a dry tissue and subsequently a tissue moistened with tap water.


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48, 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, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: Edema observed after 1 h was fully reversible within 24 h
Irritant / corrosive response data:
The skin of all animals showed very slight edema, and slight to well-defined erythema. In one animal all effects had disappeared within 3 days, while in the other two animals very slight redness persisted until day 7.
Other effects:
Two of the animals had slight diarrhoea for a short period of time during the observation period. According to the authors, this was probably not related to exposure to the test substance. Other signs of systemic intoxication were not observed in any of the rabbits.
The test article itself could not be easily removed from the skin using dry and wet tissues, and the exposed skin felt slightly sticky for one to two days after dosing.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification