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:
09 October 1986 - 23 October 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliability 1 is assigned because the study is conducted according to OECD TG 401 (but there is no data on compliance with GLP), without deviations that influence the quality of the results.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 110 - 147 g
- Fasting period before study: overnight
- Housing: groups by sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Labsure LAD 1)
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
5000 mg/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 and weighing: The animals were observed soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days animals were observed at least once in the morning and at the end of the experimental day. Individual body weights were recorded on day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, macroscopic post mortem examination (abdominal and thoracic cavities)
Statistics:
Not relevant
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed.
Clinical signs:
Pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, pallor of the extremities and diarrhoea were observed in all rats on the day of dosing. On day 2 pilo-erection persisted in all rats. There were no other clinical signs noted and recovery was apparently complete by day 3 (as judged by external appearance and behaviour).
Body weight:
Bodyweight gains were recorded for all rats on day 8 and 15.
Gross pathology:
Terminal autopsy findings were normal.

Results of the preliminary study indicated that the acute median lethal oral dose of Floral Super was >5000 mg/kg bw, as no mortality was observed in the treated animals (2 males, 2 females).

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity test showed an LD50 of >5000 mg/kg bw. Based on these results, the substance does not need to be classified for acute oral toxicity according to EU classification criteria.
Executive summary:

In this study, 10 rats (5 males and 5 females) were administered the substance at a single dose level of 5000 mg/kg bw. The rats showed no mortality, but some clinical signs were noted on the first 2 days after dosing. A body weight increase was noted in all rats during the observation period (14 days). Necropsy was performed by opening the abdominal and thoracic cavities and checking the macroscopic appearance of the organs, but no abnormalities were found. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

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

In this study, 10 rats (5 males and 5 females) were administered the substance at a single dose level of 5000 mg/kg bw. The rats showed no mortality, but some clinical signs were noted on the first 2 days after dosing. A body weight increase was noted in all rats during the observation period (14 days). Necropsy was performed by opening the abdominal and thoracic cavities and checking the macroscopic appearance of the organs, but no abnormalities were found. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
The result of this study is reliable and adequate for covering this endpoint.

Justification for classification or non-classification

According to the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP), the substance does not have to be classified as acute toxic by the oral route.