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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

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

Constituent 1
Chemical structure
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.