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Description of key information

LD50, oral, m/f > 5000 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:
other: read across from analogu substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 194 g; females: 192 g
- Fasting period before study: NA
- Housing: 5/cage
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 9.10.1986 To: 23.10.198
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
25% in deionised water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 2x10 mL/kg bw with a 30 min interval between both dosages
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The application volume of 20 ml/kg body weight was administered in two sub-applications of 10 ml body weight in each case at an interval of approx. 30 minutes.

Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs&death: frequently fisrt day; thereafter twice daily
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
As well as unspecific signs of intoxication the animals also exhibited diarrhoea. In addition, red discoloration of the hairless skin was observed. The substance was eliminated via the faeces and the urine, the urine still having a slight red colouration 14 days p.a.
Body weight:
The Bodyweight was not affected by the treatment
Gross pathology:
Post-mortem examination of the animals killed at the end of the experiment revealed a pink colouration of the connective and fatty tissue, of the pancreas, the bladder, the testes and the uterus.
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.
Executive summary:

The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

The analogue substance was tested for acute oral toxicity in an in-vivo studies following OECD 401 (NONS dossier, 1988).

For the acute oral toxicity five males and five females of Wistar were dosed and the LD50, m/f > 5000 mg/kg bw.

Based on the read across considerations same results apply to the test item

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be > 5000 mg/kg bw in the chosen reference test, which does not classified the substance.