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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:
1996-11-20 to 1996-12-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992-07-17
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hexanoic acid, 2-ethyl-, zinc salt, basic
EC Number:
286-272-3
EC Name:
Hexanoic acid, 2-ethyl-, zinc salt, basic
Cas Number:
85203-81-2
Constituent 2
Reference substance name:
286-242-3
IUPAC Name:
286-242-3
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 1290 - 1555 g
- Housing: individually in labelled cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day. Hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water (ad libitum): tap-water diluted with decalcified water
- Acclimation period: at least 5 days before start of treatment

A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Relative humidity: 50%
- Air changes: approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the test substance

Duration of treatment / exposure:
4 hours
Observation period:
approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after the removal of the dressing and test substance
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10 X 15 cm^2). The test substance was applied to the skin of one flank, using a surgical gauze patch of 2 X 3 cm. The patch was mounted on Micropore tape (Supplier 3M, St. Paul, U.S.A.), which was wrapped around the abdomen and secured with Coban elastic bandage (Supplier 3M, St. Paul, U.S.A.).

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: four hours after the application

SCORING SYSTEM: according to the Draize scoring system
Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate the scoring.
Description of all other (local) effects were recorded.

OBSERVATIONS
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body weight: day of treatment (prior to application).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Thick layer of scales and bald skin were observed on day 7 and 14, respectively.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Yellow discolouration of the skin in 40% of the treated area was observed at the 72 hour observation as well as on day 7. Thick layer of scales and bald skin were observed on day 7 and day 14, respectively.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Yellow discolouration of the skin and thick layer of scales were observed on day 7. Bald skin was observed on day 14.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Exposure to the test substance resulted in well-defined or moderate to severe erythema and slight or moderate oedema in the treated skin areas of the three rabbits. Yellow discolouration of the skin was noted in two animals 72 hours and/or 7 days after exposure. A thick layer of scales was observed after 7 days and bald skin after 14 days in all animals.
The skin irritation had resolved within 21 days after exposure in all animals.
There was no evidence of a corrosive effect on the skin.
Greasy remnants of the test substance were present on the skin of all animals on day 1.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is not classified.