Lyase, pectate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 22, 1999 to May 5, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC directive 92/69/EEC

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lyase, pectate

EC Number:

232-766-9

EC Name:

Lyase, pectate

Cas Number:

9015-75-2

Molecular formula:

Not available

IUPAC Name:

Pectate lyase IUBMB 4.2.2.2

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.

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:

liquid

Details on test material:

- Lot/batch No.: PPE 6345
- Expiration date of the lot/batch: 2008-11-30
- Stability under test conditions: Stability at ambient temperature >4 hours
- Storage condition of test material: Stored below minus 18 degrees of C in the dark.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Avlslaboratorium, Ejby, DK
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Not specified
- Fasting period before dosing: 20 hours prior to dosing and until 1 hour after the last dosing procedure.
- Housing: Barriered rodent facility with control of temperature and humidity. Five of the same sex per cage in transparent plastic boxes with wire grid tops with aspen wood chips as bedding.
- Weight at the end of the acclimatisation period: Males 172-184 g, females 137-147 g.
- Diet: Altromin rat/mouse Breeding 1320 diet pellets ad libitum
- Water: Tap water added citric acid to pH 2-3 ad libitum
- Acclimation period: 5 days

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

IN-LIFE DATES: From: 1999-02-26 To: 1992-03-12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Undiluted test material.

Doses:

Dose volume was 24 mL/kg bodyweight. The animals were dosed twice with 12 mL/kg bodyweight within 2 hours.
24 mL/kg bodyweight is equivalent to 2064 mg TOS/kg.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical symptoms after the first and second dosing procedure and 2 hours after the last dosing. Thereafter clinical observations were carried out once a day for the following 14 days. Animals were weighed on day 1 (before dosing) and on day 8 and before necropsy on day 15.
- Necropsy of survivors performed: yes

Statistics:

No

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 24 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 064 mg/kg bw

Based on:

other: Total Organic Solids (TOS)

Mortality:

No animals died during the observation period.

Clinical signs:

other: No clinical symptoms were seen during the observation period.

Gross pathology:

Effects on organs:
Macroscopic examination of animals killed on Day 15 of the observation period did not reveal any treatment-related findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of toxicity were observed for pectate lyase tested on rats treated with a single oral dose of 2064 mg total organic solids/kg, which was the highest possible dose at dose volume 24 mL/kg, using the undiluted test item.

Executive summary:

The objective of the study was to assess the acute toxicity of pectate lyase when administered by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days.

The study was conducted in accordance with the OECD Guideline No 401, 1987 “Acute Oral Toxicity”. The limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 2x12 mL/kg bodyweight of the undiluted test material.

No clinical signs were observed and the overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.

In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2064 mg Total Organic Solids (TOS)/kg.