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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test substance was tested in solution approx. in 75 % in 2−Methoxy−1−methylethylacetate/Solventnaphtha 100 (8:17)
Appearance: colourless to yellowish liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: CHR. FRED LEUSCHNER & CO., 24601 Loehndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 3.5-4.5 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: separately in cages with dimensions of 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 0-16352 Schoenwalde)
- Diet and water: ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: unchanged (no vehicle), but commercial product tested with a content of 75 % act. ingr. in solvent
Controls:
other: the surrounding untreated skin served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Until changes had completely subsided, however for not more than 14 days after application.
Number of animals:
3
Details on study design:
TEST SITE
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. A dose of 0.5 mL was applied to the test site (area: approx. 6 cm²). The test substance was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period. The surrounding untreated skin served as a control.
The skin sites were evaluated immediately before the application of the test substance. After the 4-hour exposure period the patch was removed and the skin sites were evaluated. Scores were taken 60 minutes, 24, 48 and 72 hours and 4 to 7 days after patch removal.
- Area of exposure: approximately 6 cm²

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score after 72 h: 0.3
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

An acute skin irritation/corrosion test according to OECD 404 was conducted on 3 rabbits with the test substance, which is 75 % in solvent. The following effects were recorded after 4 hours exposure under semiocclusive condition to 0.5 mL test substance: An erythema (grade 1) was observed in animal no. one 24 hours to 6 days after patch removal, in animal no. three 24 hours after patch removal. There were no systemic intolerance reactions.