Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, Draize-Test.

Data source

Reference
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics"; Division of Pharmacology, FDA; according to the Draize Test, 1959
GLP compliance:
no

Test material

Reference
Name:
Unnamed

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 2.5 kg
- Housing: single
- Diet (ad libitum): Hoeing 222
- Water (ad libitum): not specified
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-1
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated areas on test animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
24 and 72 hrs
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm
- Type of wrap if used: rubberised cloth


REMOVAL OF TEST SUBSTANCE
- Washing: not performed
- Time after start of exposure: 24 h


SCORING SYSTEM: according to the OECD/Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals, shaved skin
Time point:
other: 24 - 72 h
Score:
0.08
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see table for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals, shaved skin
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Exposition:  24 h occlusive, shaved skin    
Animal  Reading  Erythema Edema Symptoms
1 24 h 0 0  
2 24 h 0 0  
3 24 h 0 0  
4 24 h 0 0  
5 24 h 1 0  
6 24 h 0 0  
1 72 h 0 0  
2 72 h 0 0  
3 72 h 0 0  
4 72 h 0 0  
5 72 h 0 0  
6 72 h 0 0  
mean animal 1 24 - 72 h 0.00 0.00  
mean animal 2 24 - 72 h 0.00 0.00  
mean animal 3 24 - 72 h 0.00 0.00  
mean animal 4 24 - 72 h 0.00 0.00  
mean animal 5 24 - 72 h 0.50 0.00  
mean animal 6 24 - 72 h 0.00 0.00  
mean 24 - 72 h 0.08 0.00  

---

The mean erythema and edema scores of the 24 and 72 h readings of the scarified skin sites were 0.25 and 0.0, respectively. The slight erythema were fully reversible within 72 h.

Applicant's summary and conclusion

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