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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:
2012-10-21 to 2012-10-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: 21-22 weeks old
- Weight at study initiation: >2kg
- Housing: plastic rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: left side on the dorsal area
- Type of wrap if used: the test item was applied to a gauze patch, which was applied to the skin and held in place with non-irritating tape. The patch was fixed with semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Initial test in animal no. 1: no signs of irritation were seen immediately after the patch removal. Examination of the test site 1 hour after patch removal revealed erythema grade 1 which was fully reversible within 24 hours after the patch removal. No irritant or corrosive effects were observed on the intact skin of the two further female rabbits (strain NZW) of the main test after a contact time of 4 hours.

Any other information on results incl. tables

Under the conditions of the present study, the single dermal application of the test item F-D3 to three rabbits at a dose of 0.5 g showed irritant but no corrosive effects in animal no.1 which were fully reversible within 24 hours. Neither mortalities nor significant clinical signs of toxicity were observed.

Table: Dermal Irritation Evaluation

Animal
No.

Application
Site

Irritation (hours after patch removal)

1 hour

24 hours

48 hours

72 hours

T

C

T

C

T

C

T

C

1

Erythema

1

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

2

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

3

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

T = test item;       C = control;        0 – 3 = grade

Table: Individual Data

Individual Systemic and Local Findings - Animal No. 1

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

Individual Systemic and Local Findings - Animal No. 2

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

Individual Systemic and Local Findings - Animal No. 3

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

nsf = no specific findings

Table: Absolute Body Weights in kg

 

Animal No. 1

Animal No. 2

Animal No. 3

Start of Study
(weight in kg)

4.4

4.2

3.1

End of Study
(weight in kg)

4.4

4.2

3.2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No irritant effects to rabbit skin were observed in a study conducted according to current OECD guideline and under GLP.