N,N'-dithiodi-o-phenylenedibenzamide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

other: Assessment, including consideration of transformation products

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

There is no evidence that the substance is biologically active with no toxic effects reported to mammals or other organisms.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

no guideline followed

Version / remarks:

Review of data

Principles of method if other than guideline:

Because it is known that the substance quickly hydrolyses with a DT50 ca 1 day, an evaluation has been made to assess the potential toxicity of the identified transformation products

Test material

Test material information

Constituent 1

Reference substance name:

N,N’-dithiodi-o- phenylenedibenzamide

IUPAC Name:

N,N’-dithiodi-o- phenylenedibenzamide

Constituent 2

Reference substance name:

N,N'-dithiodi-o-phenylenedibenzamide

EC Number:

205-201-9

EC Name:

N,N'-dithiodi-o-phenylenedibenzamide

Cas Number:

135-57-9

Molecular formula:

C26H20N2O2S2

IUPAC Name:

N-{2-[(2-benzamidophenyl)disulfanyl]phenyl}benzamide

Details on test material:

- Name of test material (as cited in study report): Pepton 22
- Physical state: Yellow powder
- Analytical purity: 95.97%
- Lot/batch No.: 15/2673/07
- Storage condition of test material: 4 deg C over silica gel

Specific details on test material used for the study:

This is the main starting material.
Two key transformation products assessed include:
N-((1E)-4-oxo-2-sulfanylcyclohexa-2,5-dien-1-ylidene) benzamide
N-(2-((2-aminophenyl)disulfanyl)phenyl) benzamide

Test animals

Species:

other: Assessment ased mainly on rat data

Administration / exposure

Route of administration:

oral: unspecified

Details on exposure:

The review is based on potential toxicity of the transformation products that woudl form on ingestion or from secondary exposure in food or water.
Therefore, only oral exposure has been considered.

Doses / concentrations

Dose / conc.:

1 000 mg/kg bw/day (nominal)

Remarks:

Of reviews for similar substances, this was the highest dose
Some substances were dosed lowed according to parental toxicity

Examinations

Maternal examinations:

Of studies reviews, care was taken to ensure that maternal toxicity was recorded

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

other: Assessment

Remarks on result:

other: Maternal toxicity seen in some substances

Remarks:

See results of review

Maternal abnormalities

Abnormalities:

no effects observed

Description (incidence and severity):

No reproductive abnormalities reported in data reviewed

Results (fetuses)

Effect levels (fetuses)

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

No reproductive abnormalities reported in data reviewed

Fetal abnormalities

Abnormalities:

no effects observed

Description (incidence and severity):

No reproductive abnormalities reported in data reviewed
Effects on survival, size and general health seen for some substances where there was significant maternal toxicity.

Overall developmental toxicity

Developmental effects observed:

no

Applicant's summary and conclusion

Conclusions:

Because it is known that the substance quickly hydrolyses with a DT50 ca 1 day, an evaluation has been made to assess the potential toxicity of the identified transformation products
From a review of derivatives of benzamines, benzamides and toluamides, there is no evidence that this class of substance is toxic for reproduction or has potential for developmental toxicity.
This review included a well-evaluated herbicide and a biocide that had been extensively evaluated.
Some of the substances showed parental toxicity (specifically toluamides) but despite this, there were no adverse developmental effects at concentrations not causing toxicity to parental animals.
In view of the apparent low toxicity of the class if substance, including the absence of effects in testing already performed for registration of this substance, and also taking into effect limited exposure from industrial uses only and taking into account the rapid environmental transformation of the substance, there is considered to be no value in performing further animal testing.
As the substance is a potential sensitiser, it is recommended that workers at the limited number of manufacturing sites and sites where it is consumed during use take precautions when handling to minimise exposure.