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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
29 Jan - 04 Feb 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
application under occlusion; 4 animals used
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Edenor C16
- Physical state: white powder
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb: HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach/D.
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, 7343, Kuchen, D
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, 4902 Bad Salzuflen; ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): ca. 45 - 50
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days; since no scores could be observed within 3 days the experiment was cancelled due to animal welfare reasons; therefore the short observation period of 3 days does not represent a deviation to the OECD guideline)
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: ~2.5 x 2.5 cm
- Type of wrap if used: plastic foil with adhesive plasters and an acrylastic band aid

SCORING SYSTEM: Skin irritation/corrosion was evaluated according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, 2, 3, 4
Time point:
other: 4 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3, 4
Time point:
other: 4 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
No skin reactions were observed.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU