Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol

Endpoint summary

Description of key information

one Guideline study on acute toxicity by oral route and one Guideline study on acute toxicity by dermal route.

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:

26. June - 13. September 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

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:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 7-2-A
- Expiration date of the lot/batch: April 2010
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: unknown stability in PEG 300, PEG 300 was found to be a suitable vehicle in a non-GLP solubility trial
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: 11 weeks
- Weight at study initiation: 197.9 - 222.2 g
- Fasting period before study: 17-18 h
- Housing: in groups of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

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

IN-LIFE DATES: From: 26. June 2007 To: 19 July 2007

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was shosen after a non-GLP solubility trial.
- Lot/batch no. (if required): 1310049, supplier: FLUKA Chemie GmbH, CH-9471 Buchs, Switzerland
- Purity: not stated

MAXIMUM DOSE VOLUME APPLIED: not applicable

DOSAGE PREPARATION (if unusual): standard

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
not stated

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 in total

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality / Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3, and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 - 15
Body weights: On test days 1 (prior to administration), 8 and 15
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3, and 5 hours after administration on test day 1 and once daily during days 2 - 15

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

no statistics applied

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality reported

Clinical signs:

other: No clinical signs were evident in any animal during the study

Gross pathology:

no macroscopic findings

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose fo Salacos 168 ARV after single oral administration to female rats, observed over a period of 14 days is: LD50 > 2000 mg/kg bodyweight

Executive summary:

Two groups, each of three female HanRcc:WIST (SPF) ras, were treated with Salacos 168 ARV by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 (with the clinical signs) and twice dily druing 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.

All animals survived until the end of the study period.

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 recorded at necropsy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

one Guideline study available

Acute toxicity: via inhalation route

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:

26. June - 13. September 2007

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 and lot/batch No.of test material: 7-2-A
- Expiration date of the lot/batch: April 2010
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: unknown stability in PEG 300,
PEG 300 was found to be a suitable vehicle in a non-GLP solubility trial
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: 11 weeks (females), 8 weeks (males)
- Weight at study initiation: 200.0 - 265.5 g
- Fasting period before study: not applicable
- Housing: in groups of 5 per sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30 -70 %
- Air changes (per hr): 10 - 15 /h
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 26. June 2007 To: 19 July 2007

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: back of animals
- % coverage: 10 %
- Type of wrap if used: semi-occlusive drssing, fixed with elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours after application

Dose Formulation:
The test item was wighed into a tared glass beker on a suitable precision balance and the vehicle was added (weight:volume). Afterwards, the test item was warmed up to 30 °C and a magnetic stirrer and a spatula were used as homogenizers.
The temperature was measured and the test item in vehicle was applied at a temperature of 22 °C.
Application volume / kg body weight: 6 ml
Applied dose: 2000 mg/kg bw

Duration of exposure:

24 hours

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:
Mortality / Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3, and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 - 15
Body weights: On test days 1 (prior to administration), 8 and 15
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3, and 5 hours after administration on test day 1 and once daily during days 2 - 15
Local signs: Once dily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

no statistics applied

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality reported

Clinical signs:

other: No clinical signs were evident in any animal during the study

Gross pathology:

no macroscopic findings

Other findings:

The animals No.1 to 3 of the male group were free of local signs during the whole observation period. All other animals showed superficial skin exfoliation from test day 6, 7 or 9 up to test day 10, 13, 14 or 15. Additionally, slight erythema was noted in all five females from test day 2 or 3 up to test day 6, 8, 9 or 10.

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose fo Salacos 168 ARV after single dermal administration to rats of both sexes, observed
over a period of 14 days is: LD50 > 2000 mg/kg bodyweight

Executive summary:

Five male and five female HanRcc:WIST (SPF) rats were treated with SALACOS 168ARV at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 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 clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during 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 study.

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

The animals No. 1 to 3 of the male group were free of local signs during the whole observation period. All other animals showed superficial skin exfoliation from test day 6, 7 or 9 up to test day 10, 13, 14 or 15. Additionally, a slight erythema was noted in all five females from test day 2 or 3 up to test day 6, 8, 9 or 10.

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

Quality of whole database:

one Guideline study available

Justification for classification or non-classification

For the oral route the available information is conclusive but not sufficient for classification.

For the dermal route the available information is conclusive but not sufficient for classification.