4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco

Endpoint summary

Description of key information

The substance 4, 4'­lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, did not show acute oral or acute dermal toxicity. Exposure of humans by the inhalation route is unlikely.

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:

2017-10-31 to 2018-01-25

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:

2001-12-17

GLP compliance:

yes

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: R-127 Lot 170825
- Expiration date of the lot/batch: 2019-07-26

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: soluble

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: lnVivos Pte Ltd
9 Perahu Road, Lim Chu Kang, Singapore 718793
- Age at study initiation: 8-12 weeks at dosing
- Weight at study initiation: 200 - 248 g
- Fasting period before study: overnight
- Housing: individual ventilated cage system
- Diet (e.g. ad libitum): Altromin maintenance diet #1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70 %

IN-LIFE DATES: From: 2017-10-26 To: different for dosing groups, but always euthanized at end of the 14 d observation period

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: starting dose 300 mg/kg bw based upon OECD 423

Doses:

300 mg/kg bw
2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation after 30', 1, 2 and 4 h, then daily. Weighing once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: behaviour

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Animals of Group 1 and Group 2 were dosed at 300 mg/kg body weight. No adverse effect was observed on all the test animals in these two groups during dosing and observation period. Necropsy findings were normal on all the test animals in these two groups.

Gross pathology:

Necropsy findings were normal in all animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results and CLP for acute toxicity hazard categories, the acute oral toxicity of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825, is considered as Unclassified; based on OECD Guideline 423, the LD50 cut-off value of the of test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825, is 5000 mg/kg body weight or Unclassified.

Executive summary:

The acute oral toxicity of 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco was examined in a guideline study according to OECD 423.

Based on the results and CLP for acute toxicity hazard categories, the acute oral toxicity of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825, is considered as Unclassified; based on OECD Guideline 423, the LD50 cut-off value of the of test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is 5000 mg/kg body weight or Unclassified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

K1

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:

2017-10-31 to 2018-01-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127. Lot 170825
- Expiration date of the lot/batch: 2019-07-26

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: soluble

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: nVivos Pte Ltd
9 Perahu Road,
Um Chu Kang, Singapore 718793
- Age at study initiation: young adult
- Weight at study initiation: 200 - 300 g
- Fasting period before study: none
- Housing: OptiMICE Caging Systems for rats
- Diet (e.g. ad libitum): Altrom in Maintenance Diet #1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 70 %

IN-LIFE DATES: From: 2017-10-26 To: 2017-11-21

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: < 10 % of entire body surface

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 432 - 472 mg with femalles; 488 - 540 mg with males
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: yes (constant concnetration)

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: observations: 30', 1, 2 an 4 h, then daily. Weighing: once per week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No abnormality was observed on all animals during the necropsy.

Gross pathology:

No abnormality was observed on all animals during the necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the condition of this study and based on CLP for acute dermal toxicity hazard categories, the test item - 4, 4'­lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is considered as Unclassified, the LD50 value of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is more than 2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity of 4, 4'­lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, was examined ina guideline study according to OECD 402.

Under the condition of this study and based on CLP for acute dermal toxicity hazard categories, the test item - 4, 4'­lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is considered as Unclassified, the LD50 value of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is more than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1

Justification for classification or non-classification

The substance 4, 4'­lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, did not show acute oral or acute dermal toxicity.