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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:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
partly limited documentation

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Formaldehyde - SIDS Initial Assessment Report For SIAM 14
Author:
OECD SIDS
Year:
2002
Bibliographic source:
UNEP Publications
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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
short exposure period, occlusive dressing, BASF scoring
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
Formaldehyde
EC Number:
200-001-8
EC Name:
Formaldehyde
Cas Number:
50-00-0
Molecular formula:
CH2O
IUPAC Name:
formaldehyde
Details on test material:
- Name of test material (as cited in study report): formaldehyde
Specific details on test material used for the study:
TEST MATERIAL
- 40 % formalin

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
1 male (initial body weight 3.03 kg) and 1 female (intial weight 3.36 kg)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
1 mL
Duration of treatment / exposure:
20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- A patch (2.5 x 2.5 cm²) soaked with the liquid test substance corresponding to ca. 1 mL

REMOVAL OF TEST SUBSTANCE
- Washing: yes

OBSERVATION TIME POINTS
- 24, 48, 72 h and 6 and 8 days after application

SCORING SYSTEM:
- Method of calculation: 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:

In a reliable study comparable to OECD TG 404, the test substance was tested for its potential to cause acute dermal irritation or corrosion by a single topical application for 20 hours to the shaved skin of 2 White Vienna rabbits, using a patch of 2.5 cm x 2.5 cm soaked with 40 % formalin, covered with occlusive dressing. After removal of the patch the application area was washed off. 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.


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