Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 04 - August 13, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The purpose of the study was to satisfy regulatory demands because the enzyme is used for food in China.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Adopted 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: PPQ33502
- Expiration date of the lot/batch: 28 February 2022
- Stability under test conditions: The test material and dilutions in water (10% and 100%) are stable for at least 24 hours at room temperature
- Storage condition of test material: Frozen (-20°C)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: In-house bred animals
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks
- Weight at study initiation: 189.64 - 203.03 g
- Fasting period before study: The animals were not fasted prior to dose administration
- Housing: Three animals were housed in a standard Polysulfone cage (size: L 430 x B 285 x H; 200 mm) with stainless steel mesh top grill. Clean sterilized paddy husk was provided as bedding material. Sterilized paper shreds were provided as nesting material for enrichment.
- Diet (e.g. ad libitum): Nutrilab rodent feed (Manufactured by Provimi Animal Nutrition India Pvt Ltd.) ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7-9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 22.4°C
- Humidity (%): 50 to 64%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 June 2015 To: 15 July 2015

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Undiluted test material
Doses:
The animals were given two dosages of 10.3 mL/kg body weight with an interval of 4 hours between each administration (equivalent to 2102 mg TOS/kg body weight)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 min), 2 hrs (±10 min), 3 hrs (±10 min) and 4 hrs (±10 min) after each administration on Day 1 and thereafter, once daily for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Individual animal body weight was recorded on Day 1 (before test item administration for first time), Day 7 and Day 14 during the observation period.
- Necropsy of survivors performed: yes
Statistics:
No

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
other: Fixed dose method - no effects were seen
Effect level:
> 20.6 mL/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
other: Fixed dose method - no effects were seen
Effect level:
> 2 102 mg/kg bw
Based on:
other: Total Organic Solids (TOS)
Mortality:
No animals died during the study.
Clinical signs:
No clinical signs of toxicity and mortality were observed during the 14 days observation period.
Body weight:
No effect was observed on the body weights.
Gross pathology:
Effects on organs:
No gross pathological changes observed

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No signs of toxicity were observed among the rats treated with a single oral dose of 2102 mg total organic solids/kg, which was the highest possible dose at dose volume 20.6 mL/kg, using the undiluted test item.
Executive summary:

The objective of this study was to assess the acute toxicity of Xylanase when administered as a single oral dose to six rats followed by an observation period of 14 days. The purpose of the study was to satisfy regulatory demands because the enzyme is used for production of food in China.

The study was conducted in accordance with the OECD Guideline No 423, “Acute Oral Toxicity – Acute Toxic Class method”. The design of the limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 20.6 mL/kg body weight corresponding to 2102 mg/kg body weight, based on the Total Organic Solids (TOS) content of the test substance.

No mortality or clinical signs were observed after treatment and the overall body weight gain during the study was considered to be normal. The necropsy revealed no abnormalities.

In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2102 mg TOS/kg body weight, which was the highest possible dose at dose volume 20.6 mL/kg, using the undiluted test item.