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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:
07 July 2015 - 18 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
(1998)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
EC Number:
701-196-7
Cas Number:
72244-98-5
Molecular formula:
not applicable
IUPAC Name:
Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
Details on test material:
- Name of test material (as cited in study report): GABEPRO® GPM-800
- Appearance: Colourless viscous liquid
- Test substance storage: At room temperature
- Substance type: UVCB

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: 15-16 weeks
- Weight at study initiation: 3109-3281 g
- Housing: Animals were housed individually in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy). Hay and wooden sticks were abailable during the study period.
- Water: Free access to tap water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
Deviations from the maximum level of daily mean relative humidity occurred. As laboratory historical data did not indicate an effect of these deviations, the study integrity was not adversely affected by the deviations.
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 July 2015 to 18 July 2015

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Single application
Observation period:
7 days
Number of animals:
3 males
Details on study design:
STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of skin irritation observed in the first animal.

TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.

TREATMENT
The test substance was applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v).

OBSERVATIONS
- Mortality/Viability: Twice daily
- Toxicity: At least once daily
- Body Weight: Day of treatment (prior to application) and after the final observation
- Necropsy: Not performed
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and/or 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(sentinel)
Time point:
other: 24, 48 and 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: #1 (sentinel), #2 and #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Irritant / corrosive response data:
Four hours exposure to 0.5 mL of GABEPRO® GPM-800 resulted in very slight erythema and very slight oedema in the treated skin areas of the three rabbits. The skin irritation resolved within 7 days after exposure in the first animal, within 72 hours in the second animal and within 48 hours in the remaining animal. There was no evidence of a corrosive effect on the skin.
Other effects:
- Remnants of the test substance were present on the skin of all animals on Days 1 and 2
- No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred

Any other information on results incl. tables

 

 Animal

930 (sentinel)

936

935

Time after exposure

Erythema

(0-4)

Oedema

(0-4)

comments

Erythema

(0-4)

Oedema

(0-4)

comments

Erythema

(0-4)

Oedema

(0-4)

comments

   1 hour

1

1

b

1

1

b

1

1

b

 

 24 hours

1

0

c

1

0

c

1

0

c

 

 48 hours

1

0

r

1

0

-

0

0

-

 

 72 hours

1

0

r

0

0

-

0

0

-

 

   7 days

0

0

-

 

 

 

 

 

 

 

 

comments:

b.     Sticky remnants of the test substance present.

c.     Dry remnants of the test substance present.

r.      Scattered erythema.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to Regulation (EC) No 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in a skin irritation study with rabbits, performed according to OECD/EC test guidelines, GABEPRO® GPM-800 does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.
Executive summary:

In an in vivo skin irritation study in rabbits, conducted in accordance with OECD 404 (2002) and according to GLP principles, 3 male rabbits were semi-occlusively exposed for 4 hours to 0.5 mL of GABEPRO® GPM-800. Exposure resulted in very slight erythema and very slight oedema in the treated skin areas of the three rabbits. The skin irritation resolved within 7 days after exposure in the first animal, within 72 hours in the second animal and within 48 hours in the remaining animal. No signs of toxicity nor mortalities were observed. Based on the result of this study, GABEPRO® GPM-800 does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.