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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Arylesterase is also used in animal feed. Thus, in vivo skin irritation study were required to assess worker safety according to the provisions of Regulation EC 429/2008). Also, the findings from these studies were used for product classification and labelling in the US (OSHA, HSC).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
Test article characterization, provided by Sponsor, was not conducted according to GLP; however, it was conducted under Good Manufacturing Practices.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Active enzyme protein of Esterase, aryl (EC no. 232-884-0, CAS no. 9032-73-9, EC name: arylesterase, Enzyme Class no. 3.1.1.2)
Molecular formula:
Not applicable, see remarks
IUPAC Name:
Active enzyme protein of Esterase, aryl (EC no. 232-884-0, CAS no. 9032-73-9, EC name: arylesterase, Enzyme Class no. 3.1.1.2)
Constituent 2
Reference substance name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available
IUPAC Name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 3
Reference substance name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 4
Reference substance name:
Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
Constituent 5
Reference substance name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Test material form:
solid: granular
Details on test material:
- Substance type: UVCB
- Physical state: Granular

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: about 15 weeks
- Weight at study initiation: 2.7 - 3.1 kg
- Housing: individually housed in suspended wire cages. Paper bedding was placed beneath the cages and changed at least 3x a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled room; specific temperature range not reported
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 10 x 10 cm
- Type of wrap if used: 2 x 3 cm gauze patch secured with non-irritating tape. The torso was covered with a piece of porous dessing (semi occlusive) large enough to cover all dose sites with at lease 5 cm square to spare on all sides of the gauze patch. Porous, non-irritating tape was used to encircle the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test site was gently washed with distilled water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
60 mins, 24, 48, and 72 hours following exposure

SCORING SYSTEM:
Erythema and edema were scored according to the numerical Draize technique.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
There were no abnormal physical signs noted during the observation period. All body wieght changes were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No instances of erythema or edema were observed.
Executive summary:

This study was carried out in accordance with OPPTS 870.2500 to determine the irritant or corrosive effects of the test substance when applied dermally. The test substance was applied dermally (0.5 mL) to one intact site on each of the three rabbits. The test substance was kept in contact with the skin for 4 hour at which time it was removed and the animals were observed for erythema and edema at 60 minutes, 24, 48, and 72 hours following patch removal. Animals were observed for toxicological and pharmacological effects at each dermal observation period. Body weights were recorded pretest and termination.

There was no erythema or edema observed for the duration of the observation period. There were no abnormal physical signs noted during the observation period and all body weight changes were normal. In this study, the test substance is not considered a dermal irritant.