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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics - AFDO
Version / remarks:
1959
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
OB 134
IUPAC Name:
OB 134

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hs light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
intact and abraded
Vehicle:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3/sex
Details on study design:
TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: impermeable material

REMOVAL OF TEST SUBSTANCE
Dressing was removed after a 24 hour exposure.

OBSERVATION TIME POINTS
24 and 72 hours after starting of the treatment.

SCORING SYSTEM:
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythma (beet redness) to slight eschar formation (injuries in depth)

Edema formation
0 no edema
1 very slight edema (beraly perceptible)
2 slight edema (edges of area well defined by definite raising)
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n.a.
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n.a.
Remarks on result:
no indication of irritation

Any other information on results incl. tables

animal  sex skin reaction 24 h 72 h
intact skin abraded skin intact skin abraded skin
1 M erythema 0 1 0 0
oedema 0 0 0 0
2 M erythema 0 1 0 0
oedema 0 0 0 0
3 M erythema 0 2 0 0
oedema 0 1 0 0
4 F erythema 0 2 0 1
oedema 0 1 0 0
5 F erythema 0 1 0 0
oedema 0 0 0 0
6 F erythema 0 1 0 0
oedema 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to the skin of rabbits.
Executive summary:

Method

Skin irritation in rabbits according to test procedure described in AFDO (1959). Occlusive coverage was used; removal of the dressing was done 24 h after exposure. Observations for erythema and oedema were done 24 and 72 hours after start of exposure.

Results

No signs of irritation were noted on intact skin. In case of abraded skin, signs of erythema and oedema were noted 24 hours after start of exposure; 72 hours after start of exposure such signs were almost disappeared.