Peroxidase

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 11, 1996 - March 6, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Guideline 401, 1987

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

Deviation had no influence on the outcome of the study.

Principles of method if other than guideline:

Deviation from the protocol: Most of the rats included in the present study had a body weight of up to 14 g more than prescribed in the protocol at the time of dosing. Guideline dictates to use young adults in order to use the individual weight and the weight gain as sensitive parameters. The animals used in the present study had, however, more than 4 weeks left of their growth period and this deviation had therefore no influence on the outcome of the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Peroxidase

EC Number:

232-668-6

EC Name:

Peroxidase

Cas Number:

9003-99-0

Molecular formula:

Not applicable, see remarks.

IUPAC Name:

Peroxidase IUBMB 1.11.1.7

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.

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.

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.

IUPAC Name:

Lipids as a constituent of enzyme deriving from the fermentation or extraction process

Test material form:

solid: particulate/powder

Details on test material:

- Lot/batch No.: PPX 5156
- Expiration date of the lot/batch: At least 2005.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding Centre Ltd., Ejby, Denmark.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 4-6 weeks (max 8 weeks)
- Weight at study initiation: Females: 150-164 g and Males: 153-184 g
- Fasting period before study: The animals were fasted from the afternoon the day before the day of dosing until three hours after dosing.
- Housing: Rats were housed in a barrier maintained animal room
- Diet: Ad libitum (Altromin rat/mouse Breeding 1320 diet pellets)
- Water: Ad libitum (The study tap water added citric acid to pH 2-3)
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1996-03-14 To: 1996-04-02

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10.3 % w/v
- Amount of vehicle (if gavage): 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2.01 g enzyme concentrate dry matter/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Clinical signs observation: All animals were observed for any clinical symptoms before dosing and 2 and 3 hours after dosing and subsequently once a day for the following 14 days.
- Body weight observation: Animals were weighed on day 1 (before dosing), 8 and 15 (before necropsy)
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examination of the animals revealed no abnormalities related to the treatment with peroxidase.

Statistics:

Body weights and weight gains were compared between groups using a GLM procedure (General Linear Models).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 100 mg/kg bw

Based on:

other: enzyme concentrated dry matter

Mortality:

No animals died during the observation period.

Clinical signs:

other: There were no clinical signs of reaction to the treatment in any of the groups.

Gross pathology:

Necropsy findings: Macroscopic examination of the animals revealed no abnormalities related to the treatment with peroxidase.

Applicant's summary and conclusion

Interpretation of results:

other: Data insufficient for classification as 2100 mg enzyme concentrate dry matter/kg bw correspond to only 795.3 mg active enzyme protein/kg bw.

Conclusions:

Peroxidase, batch PPX 5156, can be considered as non-toxic, given as a single orally administered dose up to 2.1 g enzyme concentrate dry material/kg body weight.

Executive summary:

This study was performed to evaluate the toxic potential of the present peroxidase. The study was conducted in compliance with OECD Guideline No. 401, 1987.

The test substance was administered once orally by gavage to 2 groups of 5 male and 5 female fasted Wistar rats at dose levels of 0 and 2.1 g peroxidase, enzyme concentrate dry matter/kg body weight. Dose volume was 20 ml/kg body weight.

Clinical signs were recorded daily, whilst body weight was recorded on day 1, 8 and 15. After completion of 14 days of observation, all animals were killed and necropsied.

No mortalities occurred and no signs of toxicity were seen during the observation period. At necropsy no treatment-related findings were seen.

Peroxidase, batch PPX 5156, can be considered as non-toxic, given as a single orally administered dose up to 2.1 g enzyme concentrated dry material/kg body weight.

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