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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed before GLP guidelines and OECD guidelines were in place for industrial chemicals. The study has been performed in a lab experienced to work under GLP for pharmaceuticals. The test method is similar to the later used OECD guideline method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S. Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Substance type: organic
- Physical state: solid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: individual metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Both flanks were shaved. One flank was left shaved, the other was additionally abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g applied on a patch of 2.5x2.5 cm2
Duration of treatment / exposure:
24 hours
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 cm2
- Type of wrap if used: impermeable material

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize score for erythema, edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1.1
Max. score:
3
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1.45
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: intact skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0.8
Max. score:
2
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: intact skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not requiring classification Criteria used for interpretation of results: EU
Conclusions:
The test material applied to the skin is slightly irritant. Irritation disappears until 72 hours.
Executive summary:

The test material applied to the skin is slightly irritant. Irritation disappears until 72 hours.