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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

500-303-2

EC Name:

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

Cas Number:

115340-85-7

IUPAC Name:

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

Test material form:

liquid

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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.