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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Qualifier:
according to
Guideline:
other: Off. J. Europ. Commun. L 257, 83/467/EEC
Version / remarks:
September 16, 1983
Qualifier:
according to
Guideline:
other: Fed. Register Vol.38, No. 187, §1500.41
Version / remarks:
September 9, 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Delivery: shortly before treatment
- Aggregate state at 20°C: liquid
- Colour: yellowish
- Content of active substance: 20%
- Stability: not stable by acids
- Storage: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
males
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fortkamp, Lengerich/D
- Weight at study initiation: approx. 4400 g
- Housing: individual cage accomodation
- Diet: Altromin 2023
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: the right, respectively left flank of each animal was sheared approx. 24 hour prior to application
- Type of wrap if used: air- and vapour permeable gauze-patch (6 cm2), fixed by a gauze-bandage

REMOVAL OF TEST SUBSTANCE
- Washing: skin was cleaned using a tissue moistened with tap water and subsequently a dry tissue
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after exposure

SCORING SYSTEM:
- Method of calculation: the skin was scored according to the OECD scoring system. Mean values of scores from 24-72 hours were taken for the classification.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
Severe erythema were observed at two experimental animals during the 1-hour-observation. One of the experimental animal showed a slight edema at the 1-hour-observation. Both of the experimental animals showed beginning necrosis. After 24, 48 and 72 hours severe erythema, slight edema and necrosis were observed at the two experimental animals. The study aborted after 72 hours, because of the strong reactions. The animals were sacrificed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria