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Registration Dossier
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EC number: 201-487-4 | CAS number: 83-56-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: short report but sufficient information to be taken into account
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Single oral application of 5 different doses of test substance in lutrol to 10 male Wistar rats/dose . Observation for clinical signs and mortal was done for: 14 days; calculation of LD50 was done according to Fink und Hund (1965): Arzneimittel Forschung 15, 624
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Naphthalene-1,5-diol
- EC Number:
- 201-487-4
- EC Name:
- Naphthalene-1,5-diol
- Cas Number:
- 83-56-7
- Molecular formula:
- C10H8O2
- IUPAC Name:
- naphthalene-1,5-diol
- Test material form:
- other: solid
- Details on test material:
- no details given
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- body weight at study start: 160 - 180 g
5 aninmals/cage
no further data given
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: lutrol
- Details on oral exposure:
- Single oral application of different doses in lutrol to 10 male rats/dose
- Doses:
- 100, 500, 800, 1000, 1200 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- Single oral application of 5 different doses of test substance in lutrol to 10 male Wistar rats/dose .
Observation period for clinical signs and mortality: 14 days.
Calculation of LD50: according to Fink und Hund (1965): Arzneimittel Forschung 15, 624 - Statistics:
- Calculation of LD50 according to Fink und Hund (1965): Arzneimittel Forschung 15, 624
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 660 mg/kg bw
- 95% CL:
- >= 480 - <= 790
- Remarks on result:
- other: tremor, cramps and prone position
- Mortality:
- 100 mg animals survived
500 mg-group: 3/10 within 2-3 d after application
800 mg-group 5/10 within 2-3 days after application
1000 mg-group 9/10 within 2 days after application
1200 mg-group: 10/10 within 1 h after application - Clinical signs:
- other: tremor, prone position, cramps, crying
- Gross pathology:
- no data
- Other findings:
- no data
Applicant's summary and conclusion
- Executive summary:
Single oral application of up to 1200 mg/kg bw to 10 male Wistar rats per dose group and observation for 14 days. 100 mg/kg bw was tolerated without mortality or clinical signs. All other animals displayed tremor, cramps. prone position and cry before death occurred: 2 -3/10 at 500 mg/kg bw up to 10/10 at the highest test dose.. LD50 is 660 mg/kg bw
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