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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study submitted in the ELINCS notification dossier.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(phenylmethoxy)naphthalene
EC Number:
405-490-3
EC Name:
2-(phenylmethoxy)naphthalene
Cas Number:
613-62-7
Molecular formula:
C17H14O
IUPAC Name:
2-(benzyloxy)naphthalene

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
males: 70 days before mating and during gestation
females: 14 days before mating, during gestation and 2 weeks of lactating period.
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
600 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
3000 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
15000 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
25
Control animals:
yes, concurrent no treatment

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Increase of food consumption in amles of groups 3 and 4 before mating. In females, decrease of the food consumption and of the body weight before and during gestation, in groups 3 and 4.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Increase of food consumption in amles of groups 3 and 4 before mating. In females, decrease of the food consumption and of the body weight before and during gestation, in groups 3 and 4.

Reproductive function / performance (P0)

Reproductive performance:
effects observed, treatment-related
Description (incidence and severity):
No effects on conception rate and on gestation duration. Decrease of the implantation incidence and loss after implantationin the group 4. Litter size reduced in group 4, also observed in the group 3 but the variation is within the historical control rang

Details on results (P0)

Number of litters:
Groups 1 and 3: 24
Groups 2 and 4: 25

Effect levels (P0)

Dose descriptor:
NOEC
Effect level:
600 ppm
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: Corresponding to 43.6 mg/kg/day (males) and 71.1 mg/kg/day (females)

Results: F1 generation

General toxicity (F1)

Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Decrease of mean body weight in groups 3 and 4 after 21 days of lactation.
Gross pathological findings:
no effects observed

Effect levels (F1)

Dose descriptor:
NOEC
Generation:
F1
Effect level:
600 ppm
Based on:
not specified
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The observed effects on the offsprings are supposed to be the consequence of the effects on the P generation.
Executive summary:

A 1-generation study has been performed in the Wistar rat exposed to the substance at concentrations of 600, 3000 or 15000 ppm in the diet.

Effects on the food consumption and on the body weight of the females were observed at 3000 and 15000 ppm. At 15000 ppm, reduced implantation incidence, loss after implantation, reduced litter size were also observed.

In the offsprings of the groups treated with 3000 and 15000 ppm, a reduced mean body weight was seen on day 21 of lactation.

The NOEC is 600 ppm in both generations. The observed effects on the offsprings are supposed to be the consequence of the effects on the P generation.

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