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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
-reliability scoring based on 2002 guideline
Deviations:
yes
Remarks:
-purity of the test article and sex of the animals were not reported
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
-purity of the test article and sex of the animals were not reported
GLP compliance:
yes (incl. certificate)

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Age at study initiation: not reported
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): pellets (Ssniff MU Z, Ssniff Spezialdiaten GmbH); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 to 85
- Photoperiod (hrs dark / hrs light):12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
30 to 60 minutes, 24, 48, and 72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm squared on the back of each animals
- Type of wrap if used: semi-occlusive dressing, which was held in place by non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period, the dressing was removed and any residual sample was carefully washed away with water or an appropriate solvent.
- Time after start of exposure: 4h

SCORING SYSTEM: Same scale as the one provided in the OECD guideline


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30 to 60 min, 24, 48, and 72 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30 to 60 min, 24, 48, and 72 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30 to 60 min, 24, 48, and 72 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30 to 60 min, 24, 48, and 72 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30 to 60 min, 24, 48, and 72 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30 to 60 min, 24, 48, and 72 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified