Disodium phthalate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Short description of key information:
Data waiving: In accordance with column 1 of REACH Annex IX, a two-generation reproductive toxicity study does not need to be conducted since based on the results on the chronic studies, no adverse effects were observed on reproductive organs or tissues.

Effects on developmental toxicity

Description of key information

Key study: Read-across from experimental data on the analogue phthalic acid. Test method equivalent to OECD guideline 414. No data on GLP.
NOAEL rats maternal toxicity: 1291 mg/kg/day 
NOAEL rats developmental toxicity: 2230 mg/kg/day 

Link to relevant study records

Reference

Endpoint:

developmental toxicity

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The substance CAS 15968-01-1 (disodium phthalate) is the sodium salt of the phthalic acid CAS 88-99-3. The main assumption is that sodium is not significant in respect of all the properties under consideration. In dilute aqueous conditions of defined pH a salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. Therefore, the results obtained with the substance CAS 88-99-3 can be used for the read-across approach.

Principles of method if other than guideline:

Read-across approach from data on an analogue.

GLP compliance:

not specified

Dose descriptor:

NOAEL

Effect level:

1 291 mg/kg bw/day

Basis for effect level:

other: maternal toxicity

Dose descriptor:

NOAEL

Effect level:

2 230 mg/kg bw/day

Basis for effect level:

other: developmental toxicity

Abnormalities:

not specified

Developmental effects observed:

not specified

The substance CAS 15968-01-1 (disodium phthalate) is the sodium salt of the phthalic acid CAS 88-99-3. The main assumption is that sodium is not significant in respect of all the properties under consideration. Therefore, the results obtained with the substance CAS 88-99-3 can be used for the read-across approach.

As indicated in the European Chemical Agency Practical Guide 6 “How to report read –across and categories”, the structural grouping was realized using “OECD QSAR APPLICATION TOOL BOX” (see attachment).

Table 1: Data Matrix, Analogue Approach

CAS Number		88-99-3	15968-01-1
CHEMICAL NAME		Analogue Phthalic acid	Target chemical Disodium phthalate
PHYSICO-CHEMICAL DATA
Melting Point		Experimental results: 230 ºC	Experimental results: No evidence of melting point below 400 ºC. Decompositionin the range of 450 to 500 °C.
Boiling Point		Experimental results: Decomposes	No determination of boiling point is required since there was no evidence of melting below 400 ºC.
Density		Experimental results: 1.593 g/cm3 at 15 ºC	Experimental results: 1.67 at 20.8 ºC
Vapour Pressure		Experimental results: 8.48 x 10-5 Pa at 25 ºC	Experimental results: < 3.9 x 10 -5 Pa at 25 ºC
Partition Coefficient (log Kow)		Experimental results: 0.73	Experimental results: -2.34 at 20.1 ºC (pH 5.5)
Water solubility		Experimental results: 6250-7010 mg/L at 25 ºC	Experimental results: In the range of 45.8 to 47.9% w/w at 20 ºC.
ENVIRONMENTAL FATE and PATHWAY
Aerobic Biodegradation		Estimated data: Readily biodegradable (BIOWIN v4.10)	Estimated data: Readily biodegradable (BIOWIN v4.10)
Anaerobic Biodegradation		No data	No data
ENVIRONMENTAL TOXICITY
Acute Toxicity to Fish		No data	No data
Acute Toxicity to Aquatic Invertebrates		No data	No data
Toxicity to Aquatic Plants		No data	No data
MAMMALIAN TOXICITY
Acute Oral		Experimental results: LD50 = 2530 mg/kg (mouse)	Read-across: LD50 = 3200 mg/kg (mouse)
Acute Inhalation		No data	No data
Acute Dermal		No data	Experimental results: LD50 > 2000 mg/kg
Skin irritation / Eye irritation		No data	Experimental results: Not a skin irritant. Not an eye irritant.
Skin sensitisation		No data	Experimental results: Non-sensitising.
Repeated Dose		No data	No data
Genetic Toxicity in vitro	Gene mutation in bacteria	Experimental results: Negative	Read-across: Negative
	Chromosomal aberration	Experimental results: Negative	Experimental results: Negative
	Mammalian gene mutation	No data	Experimental results: Negative
Genetic Toxicity in vivo		Experimental results: Negative	Read-across: Negative
Carcinogenicity		No data	No data
Reproductive Toxicity: developmental toxicity		Developmental toxicity: No evidence of developmental toxicity. NOAEL, maternal toxicity= 1021 mg/kg bw/day; NOAEL, developmental toxicity= 1763 mg/kg bw/day	Read-across: No evidence of developmental toxicity. NOAEL, maternal toxicity= 1291 mg/kg bw/day; NOAEL, developmental toxicity= 2230 mg/kg bw/day

Conclusions:

Based on experimental data, the read-across approach is applied and the NOAEL for the substance is 1291 mg/kg bw/day (maternal toxicity) and 2230 mg/kg bw/day (developmental toxicity).

Executive summary:

The substance CAS 15968-01-1 (disodium phthalate) is the sodium salt of the phthalic acid CAS 88-99-3. The main assumption is that sodium is not significant in respect of all the properties under consideration. In dilute aqueous conditions of defined pH a salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. Therefore, the results obtained with the substance CAS 88-99-3 can be used for the read-across approach.

Based on experimental data, the read-across approach is applied and the NOAEL for the substance is 1291 mg/kg bw/day (maternal toxicity) and 2230 mg/kg bw/day (developmental toxicity).

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

2 230 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

Read-across approach. Klimisch 2.

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Key study: Read-across from experimental data on the analogue phthalic acid. Test method equivalent to OECD guideline 414. No data on GLP.

NOAEL rats maternal toxicity: 1291 mg/kg/day

NOAEL rats developmental toxicity: 2230 mg/kg/day

Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available.

Justification for classification or non-classification

Based on the available information, the substance is not classified as toxic for reproduction.