Registration Dossier
Registration Dossier
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EC number: 205-011-6 | CAS number: 131-11-3
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study is not assignable because of limited reporting in times before GLP.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Teratogenicity of Phthalate Esters in Rats
- Author:
- Singh AR et al.
- Year:
- 1 972
- Bibliographic source:
- J. Pharm. Sci. 61 (1): 51-55
- Reference Type:
- secondary source
- Title:
- Toxicity Profile, Dimethylphthalate, November 1987
- Author:
- BIBRA
- Year:
- 1 987
- Bibliographic source:
- BIBRA
- Title:
- No information
- Author:
- Brandt K (1985). J. Amer. Coll. Toxicol. 4 (3): 267-303
- Title:
- No information
- Author:
- Cornfield J and Mantel N (1950). Am. Statist. Ass. J. 45: 181
- Title:
- No information
- Author:
- TSCAT 20645, Doc I.D. 878213812, N, 01.03.1971, E.I. Dupont|Denemours & Co., Inc.
- Title:
- No information
- Author:
- Weil CS (1952). Biometrics 8: 249
Materials and methods
- Principles of method if other than guideline:
- other: Acute toxicity was tested via intraperitoneal injection in female Sprague-Dawley rats
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethyl phthalate
- EC Number:
- 205-011-6
- EC Name:
- Dimethyl phthalate
- Cas Number:
- 131-11-3
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 1,2-dimethyl benzene-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dimethyl phthalate; CAS-No.: 131-11-3; Supplied by Matheson, Coleman and Bell, Cincinnati, Ohio;
- Analytical purity: purity not specified.
- Other: no further data
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 000 mg/kg bw
Any other information on results incl. tables
95% confidence limits = 3 - 5.3 g/kg bw.
original data: 3.375 ml/kg
Applicant's summary and conclusion
- Executive summary:
The study is not assignable due to limited reporting in times before GLP. However, this study provides information about mortalities after intraperitoneal injection of the test substance in female rats. This study was carried out as a preliminary experiment prior to a teratogenicity study.
An LD50 of ca. 4000 mg/kg bw is reported.
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