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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
Study period:
Aug - Sep 1981
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:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schröpfschnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days.
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: standard rabbit food (NAFAG, No. 814, Gossau SG); ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol (PEG 400) + saline (70:30 parts)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%

VEHICLE
- Concentration (if solution): polyethylene glycol (PEG 400) + saline (70:30 parts)

Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches, covered with an impermeable material

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

OBSERVATION TIME POINTS
upon removal and during an observation period of 7 days

SCORING SYSTEM:
Erythema and eschar formation:
No erythema.....................................................0
Very slight erythema (barely perceptible)........1
Well defined erythema......................................2
Moderate to severe erythema..........................3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)....................4
Total possible erythema score 4

Edema formation:
No edema.................0
Very slight edema (barely perceptible)............................................1
Slight edema (edges of area well defined by definite raising).........2
Moderate edema (raised approximately 1 mm).................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure).............4
Total possible edema score 4

Assessment of irritation:
0
0.1-1.0 = minimal
1.1-2.0 = slight
2.1-4.0 = moderate
4.1-6.0 = marked
6.1-8.0 = extreme

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance was found to cause a minimal irritation when applied to abraded rabbit skin.
There were no irritating effects when the test substance was applied to intact skin.
Other effects:
No signs of systemic intoxication were observed throughout the whole test period.

Any other information on results incl. tables

Table 1: Calculation of the primary skin irritation index

 

MEAN REACTION SCORE

 

Time after exposure hours

eryth e ma

edema

 

 

 

 

intact skin

abraded skin

intact skin

abraded skin

24

0

0.3

0

0

72

0

0.2

0

0

 

 

 

 

 

total

0

+

0.5

+0

+

0

=

0.5

primary irritation index = 0.5 : 4 = 0.1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present experiment the test substance was found to cause a minimal irritation when applied to abraded rabbit skin.
The calculated primary irritation index was 0.1.
There were no irritating effects when the test substance was applied to intact skin.