Registration Dossier
Registration Dossier
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EC number: 203-350-4 | CAS number: 105-99-7
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation is insufficient for assessment. The study was performed in the early seventies, i.e. prior to implementation of current guidelines. Only very limited information is provided. No guideline was followed.
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryonic-fetal toxicity and teratogenic effects of adipic acid esters in rats
- Author:
- Singh, A.R. et al.
- Year:
- 1 973
- Bibliographic source:
- J Pharm Sci 62(10):1596-600
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Within an embryonic-fetal toxicity and teratogenicity rat study using i.p. injection for treatment, the acute toxicity first was determined. For this purpose, graded doses of the test item were administered by i.p. injection to rats and the LD50 was derived.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- 1,6-dibutyl hexanedioate
- Details on test material:
- - Name of test material (as cited in study report): Di-n-butyl adipate
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague Dawley, Inc., Madison, WI, USA
- Weight at study initiation: 175-225 g
- Diet: Purina laboratory chow, ad libitum
- Water: tap water ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- unchanged (no vehicle)
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- Observation period: 7 days
- Statistics:
- LD50 determined according to Karber's Method as modified by Cornfield and Mantel (Amer Statist Ass, 1950, 45:181).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5.244 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 4.902 - <= 5.61
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
