L-arabinose

Endpoint summary

Description of key information

In an acute oral toxicity study in rats according to OECD Guideline 423, the determined LD50 was above 2000 mg/kg bw.

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:

June 20, 2017 - July 13, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17th December 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

30 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

TOXI-COOP ZRT.1045 Budapest, Berlini u. 47-49.Hungary

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No. of test material: AD16081001
- Expiration date of the batch: 2019-08-09

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Stable under ambient conditions

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: All doses were formulated in the vehicle (water). Concentration of formulations were adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 mg/mL. Formulations were prepared just before the administration and stirred continuously during the treatment.

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old (both groups)
- Weight at study initiation:
first group: 185 g
second group: 189 - 192 g
- Fasting period before study: The day before treatment the animals were fasted. The food but not water was withheld overnight. The food was given back 3 hours after the treatment.
- Housing: 3 animals/sex/cage in Type III polypropylene/polycarbonate; rat type cages with a solid floor, stainless steel wire covers and self-feeding baskets.
- Diet: ssniff® SM R/M-Z+H complete diet (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum.
- Water: tap water from watering bottles ad libitum.
- Acclimation period:5 days for group 1 and 6 days for group 2

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: Test substance is soluble in vehicle.

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was selected on the basis of the available information about the test item.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female animals per dose (3 animals per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and once per day for 14 days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The body weight was recorded on day 0 (shortly before the treatment), on day 7 and on day 15 with a precision of 1 g, respectively.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, gross pathology

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test substance did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw (group 1 and 2, step 1 and 2).
All rats in step 1 and step 2 survived until the end of the 14-day observation period.

Clinical signs:

other: No treatment related symptoms were observed in the 2000 mg/kg bw test item dose groups (group 1 and 2, step 1 and 2) throughout the 14-day post-treatment period.

Gross pathology:

No pathological changes were found related to the test substance during the macroscopic examination of animals.

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo acute oral toxicity study in rats according to OECD TG 423, the determined LD50 was greater than 2000 mg/kg bw.

Executive summary:

The assessment of the acute oral toxicity of the test substance was carried out using the class method according to OECD TG 423. Two groups of Wistar rats (Crl(WI)) were given a single oral dose of the test item at a concentration of 2000 mg/kg bw. The method was conducted using a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. The starting dose was selected on the basis of the available information about the test item. No animal died in the first step at 2000 mg/kg bw dose level, so three further female rats were treated with the same (2000 mg/kg bw) dose. No animal died in the second step. The stopping criteria of Annex 2d of OECD TG 423 were met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

Lethality, Clinical symptoms and Body weight:

No lethality was noted following oral administration of a single dose of 2000 mg/kg bw dose groups.  No clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of all experimental animals were normal. The body weight development was normal in all animals.

Gross pathology:

All animals survived until the scheduled autopsy on Day 15. All organs of all animals proved to be free of gross pathological changes.

Evaluation:

The method used is not intended to allow for the calculation of a precise LD50 value. However for this acute oral toxicity study with the test item in rats the determined LD50 is above 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study.

Additional information

The assessment of the acute oral toxicity of the test substance was carried out using the class method according to OECD TG 423. Two groups of Wistar rats (Crl(WI)) were given a single oral dose of the test item at a concentration of 2000 mg/kg bw. The method was conducted using a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. The starting dose was selected on the basis of the available information about the test item. No animal died in the first step at 2000 mg/kg bw dose level, so three further female rats were treated with the same (2000 mg/kg bw) dose. No animal died in the second step. The stopping criteria of Annex 2d of OECD Guideline No. 423 were met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

Lethality, Clinical symptoms and Body weight:

No lethality was noted following oral administration of a single dose of 2000 mg/kg bw dose groups.  No clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of all experimental animals were normal. The body weight development was normal in all animals.

Gross pathology:

All animals survived until the scheduled autopsy on Day 15. All organs of all animals proved to be free of gross pathological changes.

Evaluation:

The method used is not intended to allow for the calculation of a precise LD50 value. However for this acute oral toxicity study with the test item in rats the determined LD50 is above 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test substance is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the the eleventh time in Commission Regulation (EU) 2018/669.