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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)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study, scientifically acceptable

Data source

Referenceopen allclose all

Title:
No information
Author:
CERHR (2000) NTP-CERHR Expert Panel Report on Di-n-Butyl phthalate. Center for Evaluation of Risks to Human Reproduction, USA.
Title:
No information
Author:
Morrissey, R.E. et al.: Fundamental and Applied Toxicology |13, 747-777 (1989).
Title:
No information
Author:
Reel, J.R. et al.: Di(n-Butyl) Phthalate: Reproduction and |Fertility Assessment in CD-1 Mice when Administered in the |Feed (28.11.1984), NTIS PB85-144798.

Materials and methods

Principles of method if other than guideline:
Method: other: nach Reel et al., Amer. Coll. Toxicol. 4, 147-162
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: A01-03:Dibutyl phthalate, Purity 99%

TS-Freetext:
Dibutyl phthalate, Purity 99%

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
Exposure period: 115 days (including 7 d premating and 98 d during cohabitation)
Premating exposure period (males): 7 days
Premating exposure period (females): 7 days
Duration of test: 115 days
Frequency of treatment:
continously via diet
Doses / concentrations
Remarks:
Doses / Concentrations:
0.03, 0.3 and 1.0% (ca. 40, 420 und 1410 mg/kg)
Basis:

Control animals:
yes, concurrent no treatment

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
420 mg/kg bw/day

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
420 mg/kg bw/day

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:
In the highest dosage negative effects on the fertillity index, the number of litter, the number of living-born offsprings and the weight of the pubs were observed. The two lowest dosage showed no effects on the fertillity. The male offspring seemed to be more resistant in relation to the toxic effect of the test substance than the female: in all dose groups the relative relationship of the male pubs was above the control level. An second study showed significant effects on the fertillity - if the male control animals were mated to female animals of the 1% group. The number of living-born offspring, as well as the absolute and relative weight of the offspring were clearly decreased in thess crossings. The F0 generation of animals of the high dose group showed a decreased body weight (only male animals) and increased liver weight; the absolute and relative uterus weight was likewise degraded in females. The macroscopic evaluation and the histopathologie did not show adverse results in testicles, epididymis, prostate, seminal vesicle, ovaries, fallopian tubes, uterus and vagina.

Applicant's summary and conclusion