[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21st September 2016 to 2nd November 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

D-fructose and D-glucose and reaction products of D-fructose and D-glucose and hexamethylenediamine

IUPAC Name:

D-fructose and D-glucose and reaction products of D-fructose and D-glucose and hexamethylenediamine

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS Limited
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Body weights did not exceed +/- 20% of the mean body weight at the start of treatment
- Fasting period before study: Overnight
- Housing: Randomly allocated to cages
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet allowed throughout the study
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test substance was used as supplied for dosing at 2,000 mg/kg bw (1.57 mL/kg). For administration of 300 mg/kg bw, test substance was formulated in water.

VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Usual vehicle.

Doses:

Starting dose level: 300 mg/kg
Next dose level: 2000 mg/kg

No. of animals per sex per dose:

For dose level 300 mg/kg: 1 animal
For dose level 2000 mg/kg: 5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations every 30 mins, 1, 2 and 4 hours after dosing and then daily for 14 days. Weights recorded on Day 0, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

For dose level 300 mg/kg no mortality observed
For dose level 2000 mg/kg no mortality observed

Clinical signs:

other: For dose level 300 mg/kg no signs of systemic toxicity observed For dose level 2000 mg/kg no signs of systemic toxicity observed

Gross pathology:

For dose level 300 mg/kg no abnormalities were noted
For dose level 2000 mg/kg no abnormalities were noted

Any other information on results incl. tables

See attached for tabulated information

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The substance does not meet the criteria for classification according to Regulation (EC) 1272/2008.

Executive summary:

The study is comparable to OECD 420 guideline with no deviations. Female Wistar rats were gavaged with pre-reacted hexamethylenediamine and glucose/fructose with a high solids binder at concentrations of 300 mg/kg bw and 2000 mg/kg bw. The LD50 value was determined to be greater than 2000 mg/kg body weight.