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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 August 1999 - 25 February 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer LR 8956X- Physical state: Liquid / Yellowish, clear- Analytical purity: 94.9 g/100 g- Lot/batch No.: Partie 10- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Age at study initiation: Young adult animals- Weight at study initiation: animals of comparable weight (150g - 300g) (+/- 20% of the mean weight)- Housing: stainless steel wire mesh cages, type DK-III (single housing)- Diet (e.g. ad libitum): ad libitum (feed assayed for chemical and microbiological contaminants)- Water (e.g. ad libitum): Tap water ad libitum per day- Acclimation period: acclimatization for at least 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): The animals were housed in fully air-contitioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees centigrade for temperature and of 30 - 70 % for relative humidity. There were no deviations from these ranges, which influenced the results of the study.- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE- Concentration in vehicle: 40.00 g/100mL- Amount of vehicle (if gavage): 5.00 ml/kg- Justification for choice of vehicle: The test substance could not be homogeneously distributed in aqua bidest.
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
3 males / 3 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Examinations performed: clinical signs and symptoms, body weight,mortality, pathology: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
Signs of toxicity noted in female animals comprised impaired general state, dyspnoea and staggering. These syptoms were considered to be unspecific toxicity symptoms. The animals appeared normal 2 days after application.The male rats did not show any symptoms.
Body weight:
The excepted body weigth gain was observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the LD50 value of the test substance was > 2,000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral LD50 of the test substance according to EPA OPPTS 870.1100, OECD Guideline 423 and EU Method B.1.

No mortality was observed at the dose level of 2,000 mg/kg bw .

Under the conditions of the study, the LD50 of the test substance was therefore >2,000 mg/kg bw.