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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to national guideline, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US Code of Federal Regulations (Title 16, Section 1500.41) [Consumer Product Safety Commission USA]
Principles of method if other than guideline:
Method: FDA method, 10% suspension in 0.5% carboxymethyl cellulose solution; 24 h, occlusive on normal and scarifized skin; skin scoring according to Draize
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 'Anthrazen reinst'
Product No. 110 147

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved (intact and abraded)
Vehicle:
other: 0.5% carboxymethylcellulose (CMC)
Controls:
other: vehicle-treated skin site
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL CMC suspension
- Concentration (if solution): 10 % (w/v)


VEHICLE
- Concentration (if solution): 0.5 % (w/v) in water
Duration of treatment / exposure:
24 h
Observation period:
72 h post-application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 squ. inch
- Type of wrap if used: impervious material (rubberized cloth)


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


SCORING SYSTEM: Draize numerical scoring system for grading irritation effects (erythema and edema)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
for 6 animals and two time points
Time point:
other: 14 h + 72 h post-application
Score:
0.79
Max. score:
8
Reversibility:
fully reversible
Irritant / corrosive response data:
Slight erythemas and/or swelling in 6/6 rabbits:
Individual scores for erythema = 0 and 1 (maximum score 4);
individual scores for edema = 0 and 1 (maximum score 4).

Applicant's summary and conclusion

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