Reaction products of ethylene glycol, urea and paraformaldehyde (EUF)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 06, 2007 to November 17, 2007 (experimental)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of ethylene glycol, urea and paraformaldehyde

EC Number:

700-934-5

Molecular formula:

No exact molecular formula can be given for a complex reaction mixture (UVCB substance).

IUPAC Name:

reaction products of ethylene glycol, urea and paraformaldehyde

Details on test material:

- Name of test material (as cited in study report): TPI 1618
- Substance type: Formaldehyde releaser
- Physical state: Colourless liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: Reaction product of ethylene glycol, urea and paraformaldehyde
- Lot/batch No.: 1118965
- Expiration date of the lot/batch: December 2008
- Storage condition of test material: dry, room temperature

Test animals

Species:

rabbit

Strain:

other: Chbb:HM (russian)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißleg
- Age at study initiation: 17 to 35 months
- Weight at study initiation: 2.7 – 2.8 kg
- Housing: individually in PPO cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): up to 70
- Air changes (per hr): 10
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: Nov 06, 2007 To: Nov 17, 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied. 0.5 mL/animal

Duration of treatment / exposure:

3 min, 1 hour, 4 hours as preliminary assessment
4 hours in three main study aniamls

Observation period:

Skin reactions were recorded: after 1, 4, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: adhesive Gothaplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hours

SCORING SYSTEM: Scoring system based on Draize


Erythema and eschar formation:
- No erythema 0
- Very slight erythema (barely perceptible) 1
- Well-defined erythema 2
- Moderate to severe erythema 3
- Severe erythema (beet redness) to
eschar formation preventing grading
of erythema 4

-- Total possible erythema score 4

Edema formation:
- No edema 0
- Very slight edema (barely perceptible) 1
- Slight edema (edges of area well defined
by definite raising 2
- Moderate edema (raised approx. 1mm) 3
- Severe edema (raised more than 1 mm and
extending beyond the area of exposure 4

-- Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

none

Any other information on results incl. tables

Table for results of skin irritation study

score (average of 3 animals investigated)	time	Erythema	Edema
average score (0 to maximum 4)	1 h	0.0	0.0
	24 h	0.0	0.0
	48 h	0.0	0.0
	72 h	0.0	0.0
average score	24h, 48 and 72h	0.0	0.0
reversibility: *		n.a.	n.a.
average time for reversibility		n.a.	n.a.
n.a. :       not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not irritating to skin of rabbits and thus, is not subject of classification.

Executive summary:

Skin irritation test in rabbits, according to OECD guideline 404, with three rabbits. Potential skin irritating properties were investigated on the intact skin (semiocclusive). The test item did not provoke any signs of oedema or erythema at any point of time.