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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the Draize-Test (1959). In contrast to OECD guideline 404 the Draize-test is done under occlusive conditions, exposure time is 24 hrs, substance is applied to intact and abrated skin, and washing of substance after application is omitted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize-Test
Principles of method if other than guideline:
The test was conducted according to the patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

GLP compliance:
no
Remarks:
GLP was not mandatory when the study was done

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: powder
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1.5 - 2.1 kg
- Housing: housing singly in metal cages
- Diet (e.g. ad libitum): Nafag (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 1
- Humidity (%): 55+/- 5%
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin from same rabbit was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hrs
Observation period:
7 days
Number of animals:
3 females, 3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: gauze patch was maintained in place by using an impermeable foil 5 x 5 cm which was fixed by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hrs

SCORING SYSTEM:
- Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all 6 animals were included
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no animal had erythema over the complete observation period
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 6 animals were included
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no animal had edema over the complete observation period
Irritant / corrosive response data:
no animal showed signs of irritation
Other effects:
Testing was done on intact and scarified skin. Only intact skin was considered for assessment of irritation.
Nevertheless the abraded skin showed no signs of irritation, too.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information