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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:
16 - 20 August 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
analytical purity not reported
GLP compliance:
yes
Remarks:
Bezirksregierung, Lüneburg, Germany

Test material

Constituent 1
Reference substance name:
130905-60-4
IUPAC Name:
130905-60-4

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremervörde, Germany
- Weight at study initiation: 2.4 – 2.8 kg
- Housing: individual housing in a battery of cages, each equipped with a paper roll disposal system
- Diet: Ssniff MÜ ZR (Alleindiät für Zuchtkaninchen), pellets, ad libitum
- Water: drinking water as for human consumption, ad libitum
- Acclimation period: at least 7 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points. 30- 60 min, 24, 48 and 72 h
Number of animals:
3 (sex not reported)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the back of each animal
- Type of wrap if used: The treated skin was covered with a semiocclusive dressing consisting of Kosmoplast R (Medilog), held in place by non-irritating tape Elastoplast R and Stülpa.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with water or an appropriate solvent
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: 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