N-isopropyl-N'-phenyl-p-phenylenediamine

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study with complete documentation. Read-across is however not justified as the basic physico-chemical data (logPow, water solubility) of N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine are not close enough to N-isopropyl-N'-phenyl-p-phenylenediamine

Justification for type of information:

See attached Read-across justification PPD_2016-02-10

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine

EC Number:

212-344-0

EC Name:

N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine

Cas Number:

793-24-8

Molecular formula:

C18H24N2

IUPAC Name:

N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine

Details on test material:

purity: 99.8% (HPLC)
A study performed with 6PPD was taken for IPPD in a read-across approach. 6PPD and IPPD are very similar substances. The difference are 3 methyl groups. Both substances have similar physico-chemical properties. They hydrolyse rapidly and have a common hydrolysis product.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Day 0 and then weekly

Test solutions

Vehicle:

yes

Details on test solutions:

a vehicle was used but the identity it is not clear from the japanese report

Test organisms

Test organisms (species):

Oryzias latipes

Details on test organisms:

20 embryos in triplacte were exposed. Final 2 cm length

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

41 d

Test conditions

Hardness:

Hardness was measured at the beginning and at the end of the test at all concentration: 47 to 53 mg/l

Test temperature:

Temperature was measured at the beginning, at the end and peridically after 1 week. Temperature was maintained at 24+-1°C.

pH:

pH was measured at the beginning and at the end of the test at all concentration: 7.5 to 8.0

Dissolved oxygen:

Disssolved oxygene was measured at the beginning, at the end and peridically after 1 week. The values were from 7.0 to 8.4 mg/l

Salinity:

Na: 10 mg/l, K: 1.3 mg/l, Ca: 16 mg/l, Mg 5.4 mg/l, Fluoride 0.13 mg/l. All other ions were

Nominal and measured concentrations:

Concentration were measured in weekly intervals. As measured concentrations were >80% of the nominal, effect values were corrected for measured values.

Reference substance (positive control):

no

Remarks:

no reference substance

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

30 d

Dose descriptor:

LOEC

Effect conc.:

0.011 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: behaviour, feeding activity, hatching rate, survival, body weight and length

Effect concentrations 2

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

0.004 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: behaviour, feeding activity, hatching rate, survival, body weight and length

Results with reference substance (positive control):

not available

Any other information on results incl. tables

Justification for read-across from 6PPD to IPPD

Only limited data for ecotox test for IPPD are available. In order to reduce the number of animal tests, most endpoints have been filled with data from 6PPD. This read-across approach is justified with the following reasons:

1. Structural similarity: As shown in the structural formula of 6PPD and IPPD, the substances are very similar and deviate only in the number of carbon atoms in the alkyl group.

2. The relevant PC-parameters (melting point, vapour pressure, partition coefficient water-octanol) are in the same order of magnitude)

3. The chemical behaviour of IPPD and 7PPD is very similar. The most important property is the hydrolysis, where both substance have nearly identical half-lifes: IPPD 3.9 hours, 6PPD 8 hours.

Additionally, some studies have been performed with the main hydrolysis product 4-Hydroxy-diphenylamine. According to ECHA (2008), REACH guidance document R7, this is justified by the rapid hydrolysis of IPPD and 6PPD (3.9 hours / 8 hours)

Applicant's summary and conclusion

Validity criteria fulfilled:

not applicable

Executive summary:

The chronic toxicity of N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine to fish was tested with Oryzias latipes in a Early-Life Stage Toxicity Test according to OECD Guideline 210. The 30d NOEC is 0.0037 mg/L. ( National Institute of Technology and Evaluation, Japan, 2003)