Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 June 1995 to 28 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): M-377
- Physical state: solid
- Appearance: garnet powder
- Storage condition of test material: room temperature and protected from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Stain: Sprague-Dawley ICO: OFA-SD (IOPS Caw)
- Age at study initiation: approximately 6 weeks
- Weight at study initiation (mean ± standard deviation): 176 ± 4 g (males); 146 ± 5 g (females)
- Fasting period before study: yes, 18 hours prior to dosing. Diet was returned 4 hours after administration of the test material.
- Housing: polycarbonate cages covered with a stainless steel lid. Each cage contained 4 - 7 animals of the same sex during acclimatisation period and 5 animals of the same sex during the treatment period.
- Diet: pelleted dietm, ad libitum
- Water: filtered drinking water (0.22 µm), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 14 June 1995 to 28 June 1995

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
(distilled)
Details on oral exposure:
The test material was prepared in the vehicle at the maximum concentration of 100 mg/mL and administered under a volume of 2 x 11 mL/kg in order to obtain a dose of 2200 mg/kg in finished product (test material) and 2000 mg/kg in active ingredient. The volume administered to each animal was adjusted according to bodyweight determined on the day of treatment.
Doses:
2200 mg/kg finished product (test material) = 2000 mg/kg active ingredient
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed frequently during the hours following administration and then at least twice daily (mortality) and at least once daily (clinical signs)
- Frequency of weighing: bodyweight measurements were taken on the day of administration (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
None of the animals died during the study.
Clinical signs:
No clinical signs were observed during the study. Pink colouration of the bedding was noted from days 4 to 8 in all animals.
Body weight:
Body weight gain of the animals was not affected by treatment.
Gross pathology:
Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was subsequently determined to be in excess of 2000 mg/kg bw. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The acute oral toxicity of the test material was determined in accordance with the standardised guidelines OECD 401 and EU Method B.1. Rats received two oral doses 1100 mg/kg under a volume of 11 mL/kg, each. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days following administration of the test material. A necropsy was performed on each animal at study termination. Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was subsequently determined to be in excess of 2000 mg/kg bw.