oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Endpoint summary

Description of key information

two Guideline studies available

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:

Jan-Mar 2004

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)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3I021
- Purity, including information on contaminants, isomers, etc.: approx 72.5% solid content

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature at about 20 °C in dry conditions
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: not stated but assumed stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not stated but assumed stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no solvent/ vehicle used
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no reactivity assumed

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
no treatment

FORM AS APPLIED IN THE TEST (if different from that of starting material)
same as received

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (not applicable)
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: not stated
- Rationale for use of males (if applicable)
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: mean 191 g
- Fasting period before study: no
- Housing: in groups of 3
- Historical data: not stated
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Microbiological status when known not stated
- Method of randomisation in assigning animals to test and control groups
selected by hand at time of delivery, no computer generated randomization program

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20. Jan 2004 (delivery of animals) To: 12 February 2004

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2759 g/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: the vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): not applicable
- Purity: purified water prepared at RCC Ltd using PURELAB Option-R unit.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no toxicity was expected for the substance at the 2000 mg/kg bw dose

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

according to Guideline

Statistics:

none

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured

Clinical signs:

other: no clinical signs noted

Gross pathology:

no findings

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of MG-60 after single oral administration to female rats, observed over a period of 14 days is:
LD50 greater than 2000 mg/kg bw (solid content)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 2004 - Jan2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 4G08
- Purity, including information on contaminants, isomers, etc.: approx 95%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature at about 20 °C in dry conditions
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: not stated but assumed stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not stated but assumed stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no solvent/ vehicle used
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no reactivity assumed

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
no treatment

FORM AS APPLIED IN THE TEST (if different from that of starting material)
same as received

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (not applicable)
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: not stated
- Rationale for use of males no rational given
- Age at study initiation: males 8 weeks, females 12 weeks
- Weight at study initiation: males ca. 250 g, females ca. 210 g
- Fasting period before study: no
- Housing: in groups of 5 per sex during acclimatization, individually during treatment and observation
- Historical data: none stated
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 deays
- Microbiological status when known: SPF
- Method of randomisation in assigning animals to test and control groups
no randomisation done (only one dose group of animals)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09 Nov 2004 (receipt) To: 30 Nov 2004

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back of animals,
- % coverage: ca. 10 % of total body surface
- Type of wrap if used: semiocclusive dressing was used as wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with lukewarm tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.5 g/ml (test item in vehicle)
- Constant volume or concentration used: yes
- For solids, paste formed: no (solution applied)

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): 0.5 g/ml (test item in vehicle)
- Lot/batch no. (if required): not applicable
- Purity: not determined

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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: twice daily for Mortatlity, Viability, daily for clinical signs, weekly for body weight
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes

Statistics:

none applied

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period

Gross pathology:

No macroscopic findings were observed at necropsy

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of MG-60 after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight

Executive summary:

Five male and five female HanBrl: WIST (SPF) rats were treated with MG-60 at 2000 mg/kg by dermal application. the test item was diluted in vehicle (purified water) at a concentration of 0.5 g/ml and administered at a volume dosage of 4 mL/kg. The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinicla signs at approximately 1,2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 1,2, 3 and 5 hours after treatment on day 1 and twice daily during test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the stud.

No clinical signs were observed during the course of the study.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

The available information is conclusive but not sufficient for classification