Peroxidase

Endpoint summary

Description of key information

Acute toxicity via the oral route has been tested. No signs of toxicity were observed in rats treated with a single oral dose of 2.1 mg enzyme concentrate dry matter/kg bw. The test was conducted according to OECD guidelines and GLP standards.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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).

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Substantial documentation on the safety of the production strain has been generated, and the enzyme test material was thoroughly characterized. The study was conducted in accordance with OECD test guidline No. 401, 1987 and in compliance with GLP. The database can thus be considered of high quality.

Justification for classification or non-classification

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

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