Dimethyl naphthalene-2,6-dicarboxylate

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

no

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl naphthalene-2,6-dicarboxylate

EC Number:

212-661-4

EC Name:

Dimethyl naphthalene-2,6-dicarboxylate

Cas Number:

840-65-3

Molecular formula:

C14H12O4

IUPAC Name:

2,6-dimethyl naphthalene-2,6-dicarboxylate

Constituent 2

Reference substance name:

Dimethyl 2,6-Naphthalenedicarboxylate

IUPAC Name:

Dimethyl 2,6-Naphthalenedicarboxylate

Test material form:

not specified

Details on test material:

Purity 99.9%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Type of inhalation exposure (if applicable):

not specified

Vehicle:

not specified

Details on mating procedure:

Male: For 2 weeks prior to mating and 2 weeks of mating.
Female: For 2 weeks prior to mating, 2 weeks of mating and throughout pregnancy until day 3 postpartum.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Male: For 2 weeks prior to mating and 2 weeks of mating.
Female: For 2 weeks prior to mating, 2 weeks of mating and throughout pregnancy until day 3 postpartum.

Frequency of treatment:

Daily

Details on study schedule:

Premating exposure period: Male: 14 days, female: 14 days

Doses / concentrations

Remarks:

Doses / Concentrations:
30, 100, 300, 1,000 mg/kg/day (in 0.5% Na-CMC)
Basis:
no data

No. of animals per sex per dose:

Male; 1,000 mg/kg, Female; 1,000 mg/kg

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Mortality:

no mortality observed

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

clinical signs

Results: P1 (second parental generation)

Reproductive function / performance (P1)

Reproductive function: oestrous cycle:

no effects observed

Reproductive function: sperm measures:

no effects observed

Reproductive performance:

no effects observed

Results: F1 generation

General toxicity (F1)

Clinical signs:

no effects observed

Mortality / viability:

no mortality observed

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

> 1 000 mg/kg bw/day

Based on:

test mat.

Sex:

not specified

Basis for effect level:

mortality

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

In an OECD 422 study, conducted according to GLP, the NOAEL (male/female rate) of NDC for reproductive performance and offspring viability >1,000 mg/kg.