Registration Dossier
Registration Dossier
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EC number: 202-974-4 | CAS number: 101-77-9
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- BASF test: Five groups of 5 rats per dose were treated intra-peritoneally with preparations of the test substance in 0.5% CMC (carboxymethyl cellulose), respectively. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-methylenedianiline
- EC Number:
- 202-974-4
- EC Name:
- 4,4'-methylenedianiline
- Cas Number:
- 101-77-9
- Molecular formula:
- C13H14N2
- IUPAC Name:
- 4,4'-methylenedianiline
- Details on test material:
- Purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean weight: male 196 g; female 165 g
Source: WIGA, Sulzfeld
Diet: Alromin-R, Altrogge
Water: ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- Application form: 2% solution in 0.5% CMC
- Doses:
- 100, 140, 200, 250, 320 mg/kg
- No. of animals per sex per dose:
- 5
- Details on study design:
- Observations:
Mortality: after 1, 24, and 48 h and 7, 14, and 21 days.
Clinical signs, pathology - Statistics:
- Litchfield-Wilcoxon for LD50 calculation.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 178 mg/kg bw
- 95% CL:
- 144 - 221
- Mortality:
- see table 1
- Clinical signs:
- 200-320 mg/kg: Dyspnea, apathy, creeping, staggering, atony, prone-lateral position, after day 7 and 21 no findings
100-140: Dyspnea, slight apathy, after day 2 and 3 no findings - Gross pathology:
- no findings
Any other information on results incl. tables
Table 1: Mortalities after treatment with test substance.
| Does (mg/kg) | Number of animals | death after 1 h | 24 h | 48 h | 7 d | 14 d | 21 d | |
| 320 | 5 m | 0/5 | 4/5 | 4/5 | 4/5 | 4/5 | 4/5 | |
| 5f | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 | 5/5 | ||
| 250 | 5m | 0/5 | 1/5 | 4/5 | 4/5 | 4/5 | 4/5 | |
| 5f | 0/5 | 0/5 | 3/5 | 4/5 | 4/5 | 4/5 | ||
| 200 | 5m | 0/5 | 0/5 | 1/5 | 2/5 | 2/5 | 2/5 | |
| 5f | 0/5 | 1/5 | 3/5 | 4/5 | 4/5 | 4/5 | ||
| 140 | 5m | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 5f | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | ||
| 100 | 5m | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 5f | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | ||
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.
