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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:
2009-08-25 to 2009-08-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
(Hungarian GLP Regulations: 9/2001. (III. 30.) EÙM-FVM joint decree of the Minister of Health and the Minister of Agriculture and Regional Development which corresponds to the OECD GLP, ENV/MC/CHEM (98) 17

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Vantex T
- Substance type: alkanolamine
- Physical state: Liquid/ yellow
- Analytical purity: 99.7 %
- Purity test date: 2009-07-13
- Storage condition of test material: Room temperature (15-25 °C)
- Other:
- Density: 960-970 g/mL (20 °C):
- The ph of the test Item was 7.0.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft., Hungary
- Age at study initiation: 10 weeks
- Weight at study initiation: at the beginning of the study: 4532-4689 g; at the end of the study 4589-4749 g
- Housing: Rabbits were individually housed in AAALC approved metal wire rabbit cages (65x65 cm with height of 45 cm, on 2 levels with a shelf to allow rabbits to climb up to stretch out). Cages are of an open wire structure and cages are placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum): ad libitum (PURINA Base - Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi ut, Hungary)
- Water (e.g. ad libitum): ad libitum (municipal tap water)
- Acclimation period: 62 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.2-22.7
- Humidity (%): 34-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24 June 2009 ( date of receipt) To: 2009-08-28

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated skin of each animal served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
at 1, 24, 48 and 72 hours after the patch removal
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: not reported
- coverage: 6 cm²
- Type of wrap if used: The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: After the treatment period, the test item was removed with body temperature water.

SCORING SYSTEM:
Scoring and Assessment of Local Reactions:
The dermal irritation scores were evaluated according to the scoring system by Draize (1959). The animals were observed for 72 hours, the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed.

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 slight eschar
formation (injuries in depth) 4
Maximum possible erythema score: 4

Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of it will be well defined
by definite raising) 2
Moderate oedema (raised appr. 1 mm) 3
Severe oedema (raised more than 1 mm and extending
beyond area of exp.) 4
Maximum possible oedema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(mean)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
(mean)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
(mean)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
(mean)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
(mean)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
(mean)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
At observation one hour after patch removal, well defined erythema (score 2) was observed in one animal, very slight erythema (score 1) was found in one animal and very slight oedema (score 1) was found in two animals.
At 24 hours after patch removal, very slight erythema (score 1) was found in one animal and very slight oedema (score 1) was found in two animals.
At 48 and 72 hours after patch removal, there were no observed signs on the skin of the treated animals.
As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.
The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.33 respectively.
The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.33, 0.33 and 0.00 respectively.
Other effects:
There was no mortality observed during the study.
There was no effect of treatment on body weight.
There were no treatment-related clinical signs noted.

Any other information on results incl. tables

Table 1. Scoring for erythema formation

Animal No./ Sex

Body weight (g)

at the beginning of the study

at the end of the study

1 h

24 h

48 h

72 h

13/ M

4689

4749

0

0

0

0

10/ M

4633

4715

1

0

0

0

6/ M

4532

4589

2

1

0

0

TOTAL

-

-

3

1

0

0

Table 2. Scoring for oedema formation

Animal No./ Sex

Body weight (g)

at the beginning of the study

at the end of the study

1 h

24 h

48 h

72 h

13/ M

4689

4749

1

1

0

0

10/ M

4633

4715

1

1

0

0

6/ M

4532

4589

0

0

0

0

TOTAL

-

-

2

2

0

0

Table 3. Mean values of skin irritation scores (24, 48, 72 hours reading)

Animal Number

Sex

Erythema

Oedema

13

male

0.00

0.33

10

male

0.00

0.33

6

male

0.33

0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to Directive 2001/59/EC, Vantex T does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Vantex T does not require classification as a skin irritant.
Executive summary:

An acute skin irritation study of the test item Vantex T was performed in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).

The test item was administered undiluted, at a single dose of 0.5 ml. Gauze was placed onto the hairless skin of the rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water of body temperature.

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

There was no mortality or systemic clinical changes related to Vantex T administration.

There was no effect of treatment on body weight.

At observation one hour after patch removal, well defined erythema (score 2) was observed in one animal, very slight erythema (score 1) was found in one animal and very slight oedema (score 1) was found in two animals.

At 24 hours after patch removal, very slight erythema (score 1) was found in one animal and very slight oedema (score 1) was found in two animals.

At 48 and 72 hours after patch removal, there were no observed signs on the skin of the treated animals.

As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.33 respectively.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.33, 0.33 and 0.00 respectively.

According to Directive 2001/59/EC, Vantex T does not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Vantex T does not require classification as a skin irritant.