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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Physical state: yellow viscous liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A.smith, Warlingham, Surrey
- Housing: in single sex groups of five in grid bottomed polypropylene cages
- Diet (e.g. ad libitum): commercial available pelleted rodent diet (modified 41B supplied by Pilsbury's Ltd of Birmingham), ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 54-64
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.25% aqueous solution of gum tragacanth
Details on oral exposure:
The material was suspended in a 0.25% aqueous solution of gum tragacanth to give a dose volume of 10mL/kg at a dose level of 5.0g/kg. The material was dosed by peroral onjection using a rubber cathether attached to a syringe of suitable capacity. After dosing animals were returned to their cages and permitted access to food and water.
Doses:
5.0 g / kg bw
No. of animals per sex per dose:
five male and five female
Control animals:
no
Details on study design:
All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Clinical signs:
No effects of treatment were observed throught the duration of the study and no abnormalities were detected at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the substance is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as the estimated oral LD50 is higher than 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study performed according the OECD Guideline 401, following overnight fasting a group of five male and five female rats were administered the test material, by peroral injection, at a dose level of 5.0g/kg bodyweight in a dose volume of 10mL/kg. All animals were observed for fourteen day period for any signs of toxicity or other effects of treatment. No effects of treatment were observed throughout the duration of the study and no abnormalities were detected at necropsy.

The results of this study indicate that the test material has no toxic effect when administrated as a single oral dose to the rat at a level of 5.0g/kg bodyweight.

Oral LD 50 Combined > 5000 mg / kg bw

Under the test conditions, test material is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as the oral LD50 is higher than 5000 mg/kg bw.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

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