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Toxicological information

Toxicity to reproduction

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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.