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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:
other: Comparable to guideline study with acceptable restrictions (analytical purity of test substance not specified, occlusive dressing according to former guideline, 24h exposure time, test substance was not removed after exposure)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing according to former guideline, 24h exposure time, test substance was not removed after exposure
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Hoechst-Wachs C Mikropulver (Bis-stearoyl/palmitoyl-ethylendiamid)
- Molecular formula: C38H76N2O2
- Molecular weight: 593
- Physical state: yellowish-white powder
- Analytical purity: technical
- Impurities (identity and concentrations): non-reacted stearic acid, concentration not specified; ethylene diamine in ppm-range
- Composition of test material, percentage of components: 60% Bis-stearoyl-ethylene diamide, 40% Bis-palmitoyl ethylene diamide

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Own breeding
- Weight at study initiation: 2.16-2.45 kg
- Housing: Separated in single cages
- Diet: Standard diet ERKA 8300 (Robert Koch oHG, Hamm), ad libitum
- Water: Ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: 6 x 3 cm, one half shaved the other additionally abraded
Vehicle:
other: Polyethylenglycol 400
Controls:
not specified
Amount / concentration applied:
500 mg in 1.2 mL vehicle on 2.5 x 2.5 cm
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 500 mg moistened with 1.2 ml polyethyleneglycol 400

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.2 ml
Duration of treatment / exposure:
24 h
Observation period:
Examinations after 24, 48 and 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: shaved flank
- Type of wrap if used: Moistened test material was applied to 2.5 x 2.5 cm cellulose pads from Hansamed, the pads were fixed to the prepared application site and covered with an indifferent, impermeable polyethylene film (6-8 cm width). Subsequently, the whole trunk of the animals was wrapped with an elastic polyurethan warp bandage (permanent bandage K, Lohmann) left in place for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritant / corrosive response data:
No erythema was observed in abraded skin, either. Edema of grade 1 was observed in 4/6 animals in abraded skin after 24 hours which was fully reversible after 48 hours.
Other effects:
No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure.

Any other information on results incl. tables

The test substance is not irritating and does not have to be classified according to the criteria of Regulation (EC) 1272/2008 and Directive 67/548/EEC.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information