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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:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline study (BASF Test) with acceptable restrictions (exposure period 20 h; occlusive dressing; application of a patch soaked with ca. 1 mL formalin; partly limited documentation, no details about the test substance)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(20 h exposure, occlusive dressing)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
40% formalin
no further details

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
1 male (initial body weight 3.03 kg) and 1 female rabbit (intial weight 3.36 kg)
no further details

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
a patch (2.5 x 2.5 cm²) soaked with the liquid (formalin) corresponding to ca. 1 mL (0.5 mL recommended in OECD 404)
Duration of treatment / exposure:
20 h (washing of test site)
Observation period:
24, 48, 72 h and 6 and 8 days after application
Number of animals:
1 male and 1 female
Details on study design:
BASF scoring system converted into the presently used grading system (OECD 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full thickness necrosis
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full thickness necrosis
Irritant / corrosive response data:
full thickness necrosis was induced in both rabbits
Other effects:
slight reduction in body weight

Any other information on results incl. tables

Skin irritation in 2 rabbits

Scorring

Erythema

Edema

Remarks

Exposure duration 20 h

24 h after initiation

Rabbit 1

Rabbit 2

 

2

3

 

3

3

 

Superficial Ne & B

Superficial Ne

48 h after initiation

Rabbit 1

Rabbit 2

 

2

2

 

3

3

 

Ne

Ne

72 h after initiation

Rabbit 1

Rabbit 2

See remarks

See remarks

 

Ne

Ne (parchmenty)

6 days

Rabbit 1

Rabbit 2

See remarks

See remarks

 

Ne (leather like)

Ne (black)

8 days

Rabbit 1

Rabbit 2

See remarks

See remarks

 

Ne (black, hardened)

Ne (black, hardened)

Ne: necrosis; B: bleeding

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
A solution of 40% formalin induced full thickness necrosis in 2 rabbits after 20 h occlusive exposure.
Executive summary:

Comparable to guideline study (BASF Test) with acceptable restrictions (exposure period 20 h; occlusive dressing; application of a patch soaked with ca. 1 mL formalin; partly limited documentation, no details about the test substance).

Two White Vienna rabbits were exposed for 20 h under occlusive dressing to a patch (2.5 x 2.5 cm²) soaked with 40% formalin. Readings were performed 24, 48, 72 h and 6 and 8 days after application. Beside edema and erythema superficial necrosis was obvious 24 h after initiation of exposure. In both rabbits full thickness necrosis were found the following days.

Conclusion: A solution of 40% formalin induced full thickness necrosis in 2 rabbits after 20 h occlusive exposure.