Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Taking into account the low acute oral toxicity and the high molecular weight, there is not considered t be any risk of acute dermal toxicity.
There is no justification to perform further animal tests on this substance
pH > 11, but in-vitro assessment shows low irritancy to skin

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Assessment based on class of substance, existing data and considering physico-chemical properties and molecular weight
Animal testing was not initially justified based on pH > 11, but in-vitro assessment shows low irritancy to skin

GLP compliance:

no

Test type:

other: Assessment

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts

EC Number:

600-775-0

Cas Number:

1067676-04-3

IUPAC Name:

Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts

Test material form:

liquid

Details on test material:

Technical grade, CA 50% in water

Specific details on test material used for the study:

The structure assessed will comprise of different oligomers and variants, but will all be of relatively high molecular weight and also all contain the thiocarbamate and bisphenol derivatives.

Test animals

Species:

other: Assessment based mainly on rat data

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Details on dermal exposure:

Most substances in the class are highly irritating to skin / corrosive and very little data exists on dermal toxicity.
Adverse effects seen in historic animal tests on this class of substance relate to local skin damage and testing was not ethical

Control animals:

not specified

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks:

Estimated

Remarks on result:

other: Estimate based on class of substance

Mortality:

No morality expected up to 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There is no evidence of systemic toxicity from skin contact.
The high molecular weight will make dermal absorption improbable

Executive summary:

Further animal testing is not justified