Registration Dossier
Registration Dossier
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EC number: 212-344-0 | CAS number: 793-24-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; original reference in Japanese, compilation of data from English summary and tables
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- publication
- Title:
- N-(1,3-Dimethylbutyl)-N'-phenyl-1,4-phenylenediamine, CAS no.: 793-24-8
- Author:
- OECD SIDS
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline for 28-day Repeat Dose Toxicity Testing of Chemicals (Japan)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 212-344-0
- EC Name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 793-24-8
- Molecular formula:
- C18H24N2
- IUPAC Name:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- test substance: 99 % purity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days; 14 days recovery period (control and 100mg/kg bw group only)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 4, 20, 100 mg/kg bw/d
Basis:
- No. of animals per sex per dose:
- 5 per sex and dose + (5 males and females control and 100 mg/kg bw recovery group)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 14 days
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: females: reversible peripotal fatty changes of the liver without an increase of liver weight, increaed total serum protein
- Dose descriptor:
- LOAEL
- Remarks:
- 100 mg/kg bw
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increase in relative liver weights accompanied by periportal fatty change, clinical chemistry and haematological parameters changed indicating an existing anaemia.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
-Mortality and time to death: none
-Clinical signs: not reported
-Body weight gain: no effect
-Food consumption: not reported
-Clinical chemistry:
20 mg/kg: females: at end of administration sig. increase of
total protein
(p<0.05); sig. decrease of inorganic phosphate (p<0.01)
100 mg/kg: males: at end of administrationsign. increase of
total protein,
creatinine, Ca, total cholesterol, sign. decrease of
albumin/globulin
(p<0.01); at end of recovery sign. increase of
triglyceride (p<0.05);
females: at end of administration sign. increase of total
protein (p<0.01),
albumin (p<0.05); sig. decrease of inorganic phosphate
(p<0.05)
-Haematology:
100 mg/kg: males: at end of administration sign. increase of
MCHC (p<0.01),
platelets (p<0.05); sign. decrease of hematocrit and MCHC
(p<0.01);
at end of recovery: sign. decrease of hemoglobin, MCV ,
MCH (p<0.05),
hematocrit (p<0.01); sign. increase of platelets (p<0.05)
females: at end of administration sign. increase of
platelets (p<0.01);
sign. decrease of hematocrit, hemoglobin, MCV, prothrombin
time, activated
partial thromboplastin time (p<0.01); at end of recovery:
sign. decrease of
hemoglobin, MCH (p<0.01), hematocrit, MCV, (p<0.05);
-Urinanalysis: 100 mg/kg: both sexes protein increased
-Organ weights: 100 mg/kg: sign. increased relative liver
weights in males and females (p<0.01) at end of
administration; reversible during recovery, but for females
still sign. increase at end of recovery (p<0.05)
-Gross pathology: 100 mg/kg: reversible liver enlargement 2
males and 1 female
-Histopathology: periportal fatty change at end of
administration at 20 mg/kg for females and at 100 mg/kg for
both sexes, effect reversible during recovery
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.
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