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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:
From December 08, 2017 to August 24, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Granja RG (Suzano/SP-Brazil)
- Age at study initiation: 10 weeks old
- Weight at study initiation: 2443.8-3006.7 g
- Housing: individually in stainless steel cages
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22.8-23.0 °C
- Humidity (%): 50-64 %
- Photoperiod: 12hrs dark / 12hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 g test substance was moistened with 0.5 mL water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removing the bandage.
Number of animals:
Three
Details on study design:
- Area of exposure: the skin of back

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Table 1. Results of Dermal Irritation in the Periods of Evaluation.

Animal’s data

Reactions evaluation after application

Reactions evaluation after removal of the patch

3 min

1 h

4 h

1 h

24 h

48 h

72 h

Animal#

Initial Weight

(g)

Final Weight

(g)

Sex

O

E

O

E

O

E

O

E

O

E

O

E

O

E

1

2443.8

2924.4

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

3006.7

3274.4

-

-

-

-

-

-

0

0

0

0

0

0

0

0

3

2852.5

2885.3

-

-

-

-

-

-

0

0

0

0

0

0

0

0

O: Oedema; E: Erythema

 

Table 2. Clinical Signs.

Animal#

Clinical Signa

After application

After removal of the patch

3 min

1 hour

4 hours

1 hour

24 hours

48 hours

72 hours

1

0

0

0

0

0

0

0

2

-

-

-

0

0

0

0

3

-

-

-

0

0

0

0

0: None visual alterations observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 404 test method test method, Everzol SR98 was non-irritant to skin. Therefore, Everzol SR98 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the BIOAGRI Study Plan for 16264.466.088.17. 0.5 g of Everzol SR98 moistened in 0.5 mL of purified water was applied to the skin of three New Zealand White rabbits and then covered with a gauze patch. After the 4 hours exposure period, the patches were removed, any residual test item removed using purified water and the animal #1 was evaluated after the application in the period of 3 minutes, 1 and 4 hours. After removing the bandage semiocclusive, three animals were examined skin reactions, behavioral and clinical alterations in approximately 1, 24, 48 and 72 hours. Adjacent untreated shaved areas of the skin were used as a negative control. Under test conditions, three rabbits do not showed any skin reactions and no treatment-related behavioral or clinical changes were observed during the observation period. On the basis of the test results given above, the response of Everzol SR98 was categorized as non-irritant.