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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:
November 06, 2007 to November 17, 2007 (experimental)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: all readings at 1, 4, 24, 48 and 72 hours revealed 0-scores
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was not irritating to skin of rabbits and is thus 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.