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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:
weight of evidence
Study period:
From 22 OCT 1985 to 26 OCT 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre d'Elevage CEGAV, St. Mars d'Egrenne, France
- Weight at study initiation: 2.4 kg (median)
- Housing: single caged in fully conditioned rooms
- Diet: grains of Ref. 112C (U.A.R, Villemoisson sur Orge, France), ad libitum
- Water: flitered water (Millipore membrane 0.22 µm), ad libitum
- both, diet and water, were tested regularly on bacterial contamination
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h after the removal of the patch
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: ~ 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: wiping with sterile gauze patch
- Time after start of exposure: 4 h

SCORING SYSTEM: according to EU B.4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation at any time
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation at any time
Irritant / corrosive response data:
There was no erythema nor edema nor any other skin reaction visible at any time during the test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the classification criteria of Regulation (EC) No. 1272/2008 the test material "ARKOFIX NFB conc" is no skin irritant under the conditions tested in this referable guideline study (EU method B.4). The test material contains relevant amounts of the submission substance. Therefore the test results are adequat to fulfil the endpoints requirements.
Executive summary:

Test material "ARKOFIX NFB conc" was subject to an acute dermal irritation /corrosion test in 6 male New Zealand rabbits according to EU method B.4. After the 4 h exposure to 0.5 mL of the undiluted test material under semi-occlusive conditions no skin effects were visible (erythema scores and edema scores: 0, in all animals at any time). Therefore the test item has not to be classified for skin irritation according to Regulation (EC) No. 1272/2008.