2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol

Acute Toxicity: dermal

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

Test material information

Constituent 1

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:

other: 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 tre

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.