Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: OECD TG 401: > 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:
experimental study
Adequacy of study:
key study
Study period:
December 09, 1980 - December 23, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reference:
Composition 1
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limited details on test material, no purity.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
other: TAC:N(SD)fBR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms, Inc.
- Age at study initiation: No data
- Weight at study initiation: males: 200 - 244g; females: 151 - 172g
- Fasting period before study: fasted overnight prior to dosing
- Housing: Animals were individually housed in stainless steel cages with wire-mesh floors
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to filtered tap water
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: December 9, 1980 To: December 23, 1980
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Individual doses, calculated on the basis of bodyweight and the dose level (mL), were administered via oral intubation tube.
Doses:
0.59, 1.00, 1.69, 2.88 and 5.00 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed frequently during the first 5 hours after dosing and twice daily thereafter
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by CO2 asphyxia, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 14th day of the observation period or at time of death if prior to scheduled sacrifice on day 14
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One male animal dosed at 5 mL/kg bw was found dead on day 1. All other animals survived for the duration of the study.
Body weight:
All animals that survived for the duration of the study gained weight. No important differences were found between dose levels or sexes.
Gross pathology:
The gross lesions found at necropsy were interpreted to be incidental findings unrelated to test article administration.
Interpretation of results:
other: Not classified.
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The acute oral toxicity test with the substance showed an LD50 of > 5000 mg/kg bw.
Executive summary:

Acute oral toxicity: In this study equivalent to OECD TG 401 and in compliance with GLP principles, 10 rats (5 males and 5 females) were administered the substance at dose levels of0.59, 1.00, 1.69, 2.88 and 5.00 mL/kg bw, resulting in the highest dose of 5000 mg/kg bw. The doses are not adjusted for density because it does not affect the study result for C&L (LD50 > 4376 mg/kg bw using relative density of 0.8753). One male animal dosed at 5 mL/kg bw was found dead on day 1. Clinical signs observed included diarrhea, salivation, lethargy, crusty nose, crusty eyes, lacrimation and loose stool and were suggestive of cholinergic-like action. The incidence of diarrhea increased with dose level.The gross lesions foundat necropsy were interpreted to be incidental findings unrelated to substance administration. The acute oral LD50 for the substance in male and female rats was determined to be > 5 000 mg/ kg bw, so it is not classified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity: In this study equivalent to OECD TG 401 and in compliance with GLP principles, 10 rats (5 males and 5 females) were administered the substance at dose levels of 0.59, 1.00, 1.69, 2.88 and 5.00 mL/kg bw, resulting in the highest dose of 5000 mg/kg bw. The doses are not adjusted for density because it does not affect the study result for C&L (LD50 > 4376 mg/kg bw using relative density of 0.8753). One male animal dosed at 5 mL/kg bw was found dead on day 1. Clinical signs observed included diarrhea, salivation, lethargy, crusty nose, crusty eyes, lacrimation and loose stool and were suggestive of cholinergic-like action. The incidence of diarrhea increased with dose level. The gross lesions foundat necropsy were interpreted to be incidental findings unrelated to substance administration. The acute oral LD50 for the substance in male and female rats was determined to be > 5 000 mg/ kg bw.

Justification for classification or non-classification

Based on the results, the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008 and its amendments.