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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:
05 Feb - 28 June 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
no data on purity available
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, slightly viscous liquid
- Analytical purity: no data available
- Lot/batch No.: 2131UG060495
- Storage condition of test material: original container at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2739 - 2903 g
- Fasting period before study: no
- Housing: individually housed in wire-mesh cages
- Diet: Purina Certified Rabbit Chow No. 5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.4
- Humidity (%): 34.7-60.2
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
8 days
Reading time points: 1, 24, 48 and 72 h and 4, 5, 6, 7 and 8 days
Number of animals:
6 (2 males, 4 females)
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: test substance was applied under a secured 2-ply gauze patch overwrapped with a gauze binder and secured with Dermiform tape

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the treatment period the sites were wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of all 6 animals
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: mean of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No oedema reactions were observed in any animal at any time point. After 0.5-1 h no erythema reactions were observed. After 24 h 2/6 animals showed erythema (grade 1), which were fully reversible within 7 days. In addition, in the 2 animals with erythema reactions desquamation was observed from Day 3 until Day 7.
Other effects:
No deaths, clinical signs of toxicity or body weight changes were observed throughout the study period.

Any other information on results incl. tables

Table 1: Individual scores from skin irritation study in rabbits.

Rabbit No.

1 (male)

2 (male)

3 (female)

4 (female)

5 (female)

6 (female)

Observation time

Ery.

Oed.

Ery.

Oed.

Ery.

Oed.

Ery.

Oed.

Ery.

Oed.

Ery.

Oed.

1 h

0

0

0

0

0

0

0

0

0

0

0

0

24 h

0

0

1

0

0

0

1

0

0

0

0

0

48 h

0

0

1

0

0

0

1

0

0

0

0

0

72 h

0

0

1d

0

0

0

1d

0

0

0

0

0

4 d

-

-

1d

0

-

-

1d

0

-

-

-

-

7 d

-

-

0

0

-

-

0d

0

-

-

-

-

8 d

-

-

-

-

-

-

0

0

-

-

-

-

Mean value

0

0

1

0

0

0

1

0

0

0

0

0

24 + 48 + 72 h

Ery.: Erythema

Oed.: Oedema

d: Desquamation

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In a skin irritation study according to OECD 404 the test item was found to be not irritating to skin. Treatment of 6 New Zealand White rabbits under semi-occlusive conditions with 0.5 ml undiluted test substance induced no edema in any animal at any time point. Slight erythema (grade 1) were observed in 2/6 animals but were fully reversible within 7 days. Furthermore no signs of systemic toxicity no effects on body weight were observed.