Formaldehyde

Skin irritation / corrosion

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

Reference

Reference 1

Reference Type:

publication

Title:

Formaldehyde - SIDS Initial Assessment Report For SIAM 14

Author:

OECD SIDS

Year:

2002

Bibliographic source:

UNEP Publications

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Reference 3

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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.