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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:
November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed equivalent to OECD 404 guideline. Non GLP. Observation period was limited to directly and 48 hours after patch removal.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation period was limited to directly and 48 hours after patch removal. Limited details on animals and environmental conditions.
GLP compliance:
no
Remarks:
not present at the time of performance.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Elintaal F
- Description: Clear colourless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Adult animals

ENVIRONMENTAL CONDITIONS
No data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12
Details on study design:
STUDY DESIGN
The test substance is brought on the intact or abraded skin under a surgical patch measuring 2.54 x 2.54 cm.

TEST SITE
Twenty four hours prior to applying the material, the hair is removed from the back of the animal with an electric clipper in such a way as to avoid abrasions.
Six rabbits are treated on the intact skin, the other on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.

REMOVAL OF TEST SUBSTANCE
Twenty four hours after the application, the dressing was removed.

The skin reactions were assessed directly (first reading) and 48 hours (second reading) after the removal of the dressings and test substance.

SCORING SYSTEM:
The irritation at the first reading was assessed according to the numerical scoring system according to OECD 404.
The second reading is carried out on the basis of the CIVO-grading system:
0 = no reaction at all
1 = very slight scaliness
2 = distinct scaliness or very slight incrustation
3 = distinct incrustation
4 = secere incrustation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema, edema and scaliness
Basis:
mean
Remarks:
animal #1, #2, #3, #4 and #6
Time point:
other: 48 hours
Score:
2
Max. score:
4
Remarks on result:
other: score intact skin
Irritation parameter:
other: erythema, edema and scaliness
Basis:
animal #5
Time point:
other: 48 hours
Score:
1
Max. score:
4
Remarks on result:
other: score intact skin
Irritation parameter:
other: erythema, edema and scaliness
Basis:
mean
Remarks:
animal #7, #8, #9, #10, #11 and #12
Time point:
other: 48 hours
Score:
2
Max. score:
4
Remarks on result:
other: score abraded skin
Irritant / corrosive response data:
Elintaal F caused moderate skin irritation. Its dermal effects consisted of very slight or well-defined erythema, very slight ischemia, slight or distinct scaliness and very slight or slight edema.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline, irritation was observed.
Executive summary:

Elintaal F was tested in a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline.

Elintaal F caused moderate skin irritation 48 hours after patch removal. Its dermal effects consisted of very slight or well-defined erythema, very slight ischemia, slight or distinct scaliness and very slight or slight edema.

As the observation period was limited to 48 hours after patch removal and no reversibility has been observed, Elintaal F should be classified as skin irritation cat.2 and should be labelled with H315: Causes skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.