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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:
48 hours
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: rangefinding study on behalf of the sensitization study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Priliminary irritation study (executed for rangefinding in the sensitisation study)
Guinea pigs were exposed interdermally by injection to a concentration of 50%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.1% DAB
After 24 and 48 hours the Erythema grade and Necrosis area were scored.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substances: clear colourless liquid; vehicle : distilled water
Stability in vehicle: at least 96 hours.

Test animals

Species:
guinea pig
Strain:
other: Albino Guinea Pig
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
other:
Preparation of test site:
other: intradermal injection & epidermal exposure
Vehicle:
water
Controls:
no
Amount / concentration applied:
50%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.1% DAB
Duration of treatment / exposure:
48 hours
Observation period:
48 hours
Number of animals:
7 animals
Details on study design:
Guinea pigs were exposed interdermally by injection to a concentration of 50%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.1% DAB
After 24 and 48 hours the Erythema grade and Necrosis area were scored.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
animal: 42
Time point:
other: 24 hours
Score:
2
Reversibility:
other: 10%: no improvement at 48 hours; 5% score improved to 1 afther 48 hours
Irritant / corrosive response data:
The Guinea pigs exposed intradermally to a concentration to 50% & 20% and 10% & 5%, were sacirficed for ethical reasons, since they showed large areas of necrosis at the sites of injection shortly after treatment.
The Guinea pig exposed epidermally to a concentration of 20% and 50% was sacrificed after 24 hours for ethical reasons; the treated skin area showed eschar formation. Oedema could not be scored in this animal.
Other effects:
Intradermal exposure: necrosis at all injection sites; diameter dependend on dose.
Epidermal exposure: 10% and 5%: erythema and oedema; <2% no effects scored.

Any other information on results incl. tables

Preliminary irritation study; skin reactions after intradermal injection

 Animal number  Conc. %   Time after injection                           
        24 hours     48 hours
     Erythema (grade)  Necrosis (mm)  Erythema (grade)  Necrosis (mm)
 40  50  *      
 40  20        
 41  10  *      
 41  5        
 42  2    10    10
 42  1    10    10
 1  0.5    7    7
 1  0.1    3    3

* the animal was sacrifieced for ethical reasons, since it showed large areas of necrosis at the sites of injetion shortly after treatment.

Priliminary study: Skin reactions after epidermal exposure

Animal number  Conc. %   Time after injection                           
        24 hours     48 hours
     Erythema (grade)  Oedema  Erythema (grade)  Oedema
39  50 4 *  -    
39  20 4 *  -    
42  10 2  1  2
42  5  2  1  1  0
2  2  0 0  0  0
2  1  0 0  0  0
2  0.5  0 0  0  0
2  0.1  0 0  0  0

* the treated skin area showed eschar formation. Oedema could not be scored. The animal was sacrificed for ethical reasons immediately after the 24 hour obeservation.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Causes burns Criteria used for interpretation of results: EU
Conclusions:
Corrosive, R34 Causes burns
Executive summary:

Intradermal and epidermal exposure to DAB concentrations (preliminary study for rangefinding for the sensitization study) induced necrosis, erythema and oedema. Some animals had to be sacrificed for ethical reasons shortly after exposure.

NOAEL: 2% (no erythema, oedema, nor sensitization)

DSD: Corrosive, R34 Causes burns

CLP: Danger, H314 Causes serious burns