oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan - Feb 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / Frande
- Age at study initiation: 11 weeks
- Weight at study initiation: ca 2090 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 Jan 2004 (receipt) To: 29 Jan 2004

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of test item

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 4 cm * 4 cm
- % coverage: no stated
- Type of wrap if used: semi-occlusive drssing, anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1/24/48/72 hours

SCORING SYSTEM:
- Method of calculation:
according to EU Guideline

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal: #1, #3

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, sparately. The mean erythema/eschar score of the three animals was 0.33, 0.67 and 0.33, respectively and the mean oedema score was 0.00 for all three animals. Very slight erythema was observed in all animals at the 1- and 24 hour reading and persisted in one animal up to 48 hours after treatment. No abnormal findings were observed on the treated skin of any animal 72 hours after treatment, the end of the observation time.

Other effects:

none observed

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the referred classification criteria, MG-60 is considere to be "not irritating" to rabbit skin. According to Draize classification criteria MG-60 is considered to be "mild irritant" to rabbit skin (P.I.I. = 0.44).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 2004 - Feb 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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.: solid content 72.5 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range 20 +-3 °C), light protected
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: assumed stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: assumed stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: assumed stable
- Reactivity of the test material with the incubation material used (e.g. plastic ware): assumed stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
- Preliminary purification step (if any):
- Final concentration of a dissolved solid, stock liquid or gel:
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle):

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution:

INFORMATION ON NANOMATERIALS
- Chemical Composition:
- Density:
- Particle size & distribution:
- Specific surface area:
- Isoelectric point:
- Dissolution (rate):

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
- Description of the formulation, e.g. formulated product for foliar application; formulated product soil application; solution in organic solvent for soil application; formulated product seed treatment; solution in organic solvent seed treatment:

OTHER SPECIFICS
- Other relevant information needed for characterising the tested material, e.g. if radiolabelled, adjustment of pH, osmolality and precipitate in the culture medium to which the test chemical is added:

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatllon sur Chalaronne, France
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 1963 - 2023 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30-70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

after instillation, no removal was done

Observation period (in vivo):

up to 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: according to EU Guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjunctivae was observed in all animals at the 1-hour reading and ersisted in two animals up to 24 hours and in one animal up to 48 hours after treatment. Slight swelling (chemosis of the conjunctivae was noted in one animal at the 1 hour examination. Slight reddening of the sclerae was evident in two animals 1 hour after treatment.

Other effects:

no other effects observed

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not induce significatn or irreversible damage to the rabbit eye.

Executive summary:

The primary eye irritation potential of MG-60 was investigated according to OECD test guideline no 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48, 72 hours after test item instillation.

The mean score was calculated across 3 Scoring Times (24, 48 and 72 hours after
instillation) for each animal for corneal opacity, Iris, redness and chemosis of the
conjunctivae, separately. The individual mean scores for corneal opacity and Iris were 0.00
for all free animals. The individual mean scores for the conjunctivae Waffe 0.67, 0.00 and
0.33 for reddening and for all free aniMals 0.00 for chemosis.
The instillation of MG-60 into the eye resulted in mild, early~onset and transient ocular
changes, such as reddening of the conjunctivae and sclerae, and chemosis. These effects
were reversible and were no langer evident 72 hours after treatment, the end of the
Observation period for all animals. No abnormal findings were observed in the cornea er Iris
of any animal at any of the examinations. No corrosion was observed at any of the
measuring intervais. No staining of the treated eyes by the test item was observed and no
Other Clinical signs of Test item related effects were observed.
Thus, the test item did not induce significant er irreversible blamage to the rabbit eye.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of
August 06, 2001 ), MG-60 is considered to be "not irritating" to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available information is conclusive but not sufficient for classification