Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA TSCA Test Guidelines (40 CFR Parts 796, 797, 798: 798.4900 Developmental Toxicity Study, September 27, 1985, and Revised Edition May 20, 1987)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,5-naphthylenediamine
- EC Number:
- 218-817-8
- EC Name:
- 1,5-naphthylenediamine
- Cas Number:
- 2243-62-1
- Molecular formula:
- C10H10N2
- IUPAC Name:
- 1,5-naphthylenediamine
- Details on test material:
- IUCLID4 Test substance: other TS: purity 99.5 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: demineralised water and 0,5% Cremophor EL
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- If on the following morning after mating procedure sperms were found in vaginal swab, the day was considered as day 0 of gestation.
- Duration of treatment / exposure:
- day 6-15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- sacrifice on day 20 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2, 10 or 50 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 25 female animals/dose
- Control animals:
- yes
Examinations
- Maternal examinations:
- From day 0 until day 20 p.c. the test animals were examined twice daily. Attention was payed to problems of general condition, appearance, behaviour, and changes of excretory products. Food and water consumption was journalized from day 0-20 p.c..
- Ovaries and uterine content:
- 0 mg/kg bw/day= 262 fetuses
2 mg/kg bw/day= 218 fetuses
10 mg/kg bw/day= 216 fetuses
50 mg/kg bw/day= 242 fetuses - Fetal examinations:
- 0 mg/kg bw/day= 262 fetuses (126 WILSON/ 136 DAWSON)
2 mg/kg bw/day= 218 fetuses (102 WILSON/ 116 DAWSON)
10 mg/kg bw/day= 216 fetuses (104 WILSON/ 112 DAWSON)
50 mg/kg bw/day= 242 fetuses (116 WILSON/ 126 DAWSON)
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
I. parental:
no pathological findings and no mortality
>= 10 mg/kg bw: reduced food consumption and reduced weight
gain
50 mg/kg bw: sporadic increased water consumption and
urine output
II. offspring:
>= 10 mg/kg bw: slight reduction in body weight (effect not
dose-dependent)
Bodyweight development:
| Dose | Weight gain (g) | ||
| mg/kg bw/day | media | adjusted | |
| Day 6 -15 p.c. | Day 0 -20 p.c. | Day 0 -20 p.c. | |
| 0 | 24,5 | 92,6 | 31,5 |
| 2 | 21,8 | 85,3 | 29,6 |
| 10 | 20,7 | 86,8 | 27,2* |
| 50 | 11,7** | 76,9* | -17,1*** |
* Statistically significant difference to control p<0,05
** Statistically significant difference to control p<0,01
*** Statistically significant difference to control p<0,001
Applicant's summary and conclusion
- Executive summary:
25 female Wistar-rats received 1,5 -naphthylenediamine by gavage (dose: 0; 2; 10; 50 mg/kg bw.) daily from day 6 to day 15 of gestation.
From 10 mg/kg bw./day the food consumption and weight gain were influenced.
In the 50 mg/kg dose group sporadic heightened urine excretion was observed and additionally in one animal an increased water consumption detected.
No meaningfull pathological-anatomical findings and no mortalities were observed.
From 10 mg/kg bw/day a marginal diminuated weight of fetuses was identified.
The NOAEL for maternal toxicity and developmental toxicity was 2 mg/kg bw/day.
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