Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March to April 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
EC Number:
243-500-6
EC Name:
2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
Cas Number:
20073-51-2
Molecular formula:
C25H46N2O5
IUPAC Name:
2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Brown Norway
Sex:
female
Details on test animals or test system and environmental conditions:
The study was undertaken in compliance with the guidelines of the “Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), USA” and “Guidelines for Laboratory Animals Facility” issued by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), India.
Compliance of these guidelines ensures the humane care of animals used throughout the experiment. It further enhances the well-being of animals which subsequently promotes a quality outcome of the experiment, for the advancement of biological knowledge, relevant to human and animals.
Project proposal for the experimentation was approved by the “Institutional Animal Ethics Committee (IAEC), JRF.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test item was held in contact with the skin using porous gauze dressing (not more than 8 ply) and a non-irritating tape (Medi tape 330, hypo-allergenic surgical tape) throughout the 24 h exposure period to prevent any loss of the test item and also to ensure that the rats did not lick or ingest it. At the end of the exposure period (24 h), the residual test item was removed using cotton soaked in RO water (freshly collected).
Duration of exposure:
24 h
Doses:
200, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
5 females
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No morbidity and mortality was observed in any rat treated with 200, 1000 and 2000 mg POLIOL MB 600/kg body weight.
Clinical signs:
Erythema, oedema, and scale were observed at the site of the test item application in rat treated with POLIOL MB 600.
Very slight erythema (score of 1) and very slight oedema (score of 1) were observed, at the site of the test item application in rat treated with POLIOL MB 600 post patch removal
Body weight:
Changes in body weight were considered within the expected range for this strain and age of rats and not influenced by the treatment with POLIOL MB 600/kg body weight.
Gross pathology:
External
External examination of terminally sacrificed rats treated at 200 mg POLIOL MB 600/kg body weight did not reveal any abnormality while scales formation was observed in rats treated at 1000 and 2000 mg POLIOL MB 600/kg body weight.
Internal
Visceral examination of terminally sacrificed rats did not reveal any abnormality.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on results of this study, an indication of the classification for POLIOL MB 600 is as mentioned below:
Globally Harmonized System of Classification and
Labelling of Chemicals (GHS): Category 5 or Unclassified
As per Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017), if test item is classified under Category 5 or Unclassified it indicate that the LD50 is found to be greater than 2000 mg/kg body weight.
Executive summary:

In this acute dermal toxicity study, five female Wistar rats (three rat for the range finding study dosed at 200, 1000, and 2000 mg/kg body weight and additional two rats for the main study, sequentially dosed at 2000 mg/kg body weight) were dermally exposed toPOLIOL MB 600for 24 h.

Based on individual body weights, the required undiluted volume (0.05 to 0.47 mL) ofPOLIOL MB 600using density 1050 mg/mL, was applied over the clipped dorsolateral thoracic surface of the skin (approximately7 cm × 5 cm body surface area).

Initially one rat was tested for a period of 24 h.Based on observations at 24 h post patch removal, additional four rats were tested sequentially. At the end of the 24 h exposure period, the residual test item was removed with a piece of cotton, soaked in RO water.Skin reactions of each rat were observed at an interval of 24, 48, and 72 h post patch removal.Rats were observed for a period of 14 days.

Erythema, oedema, and scale were observed at the site of the test item application in rat treated with POLIOL MB 600.

There was no treatment-related mortality or change in the body weight recorded.

External examination of terminally sacrificed rats treated at200 mg POLIOL MB 600/kg body weightdid not reveal any abnormality while scales formation was observed in rats treated at 1000 and2000 mg POLIOL MB 600/kg body weight. Internal examination of terminally sacrificed rats did not reveal any abnormality.

Very slight erythema (score of 1) and very slight oedema (score of 1) were observed, at the site of the test item application in rat treated with POLIOL MB 600 post patch removal.

Based on results of this study, an indication of the classificationforthePOLIOL MB 600isas mentioned below:

Globally Harmonized System of Classification and Labelling of Chemicals (GHS)                                            :          Category 5 or Unclassified

As per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017), if a test item is classified under Category 5 or Unclassified it indicate that the LD50is found to be greater than 2000 mg/kg body weight.