Registration Dossier

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:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop/Meerbusch
- Weight at study initiation: mean weight: 2.1 kg
- Housing: one per cage
- Diet (e.g. ad libitum): "muemmel z" (ssniff/Soest)
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: 4-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40 (relative humidity)
- Photoperiod (hrs dark / hrs light): according to the day light rhythm

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved intact and damaged skin
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg compound slightly thickened with water
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: double layer gauze covered by indifferent impermeable PVC (5x5 cm) foil and elastic bandage (ElastoflexR)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
other: 24 h - 72 h - 8 d
Max. score:
4
Remarks on result:
other: reading and calculation not possible due to the skin coloring by the substance
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h - 72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
other: 24 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results show that there is no corrosive potential of the substance. However, the substance can not be properly evaluated due to substance residues / coloring. The substance is regarded as slightly irritatin, however below the level of regulatory significance.