Registration Dossier
Registration Dossier
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EC number: 201-557-4 | CAS number: 84-74-2
Toxicity to reproduction
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 substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Details on test material:
- IUCLID4 Test substance: A01-03:Dibutyl phthalate, Purity 99%
TS-Freetext:
Dibutyl phthalate, Purity 99%
Constituent 1
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 generation)
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
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