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Diss Factsheets

Administrative data

Description of key information

In a former study report (Bayer 1978) single oral application of up to 1200 mg/kg bw to 10 male Wistar rats per dose group and observation for 14 days is described. The LD50 is 660 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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
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

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
660 mg/kg bw
Quality of whole database:
available data include every endpoint

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: oral application

There are 2 studies available which should be taken into account with regard to classification and labeling.

In an former study report (Bayer 1978) single oral application of up to 1200 mg/kg bw to 10 male Wistar rats per dose group and observation for 14 days is described. 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. The LD50 is 660 mg/kg bw. Based on these result the test substance was provionally classied/labeled by manufacturer/importer with R 22 = harmfull if swallowed.

In 2010 Scientific Committee on Consumer Safety (SCCS) reported of male and female rats which were given 2000 mg/kg bw test substance as single application and were observed for 14 days according to OECD TG 423 and GLP. No mortality occurred. The reported clinical findings within the first two days included hunched posture and piloerection. The LD50 value of 1,5 -naphthalenediol in Wistar rats was established to exceed 2000 mg/kg bw. However, this is a secondary citation and the individual animal data are not available.

Therefore , and due to the discrepancy of the available results, we propose not to change the classification of 1,5-naphthalenediol and to allocate 1,5-naphthalenediol to Category 4 , H302 (= harmfull if swallowed) of the acute oral toxicity group in GHS/CLP Regulation(EC) 1272/2008


Justification for selection of acute toxicity – oral endpoint
reliable study although not according to GLP

Justification for classification or non-classification

Based on the considerations above, and due to the discrepancy of the available results, we propose not to change the classification of 1,5-naphthalenediol and to allocate 1,5-naphthalenediol to Category 4 , H302 (= harmfull if swallowed) of the acute oral toxicity group in GHS/CLP Regulation(EC) 1272/2008