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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
-reliability scoring based on 2001 guideline
Deviations:
yes
Remarks:
-source/origin of test article, age of the animals, acclimatization period, individual observations of clinical signs, and specific time-points for observation period were not provided; dose volume administered was higher than recommended amount by OECD
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lycasin® 80/55
- Physical state: Liquid (clear, colorless)
- Analytical purity: 75% dry weight
- Lot/batch No.: 1773
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA CREDO (FRANCE)
- Age at study initiation: Not reported
- Weight at study initiation: Mean body weight range: 181 to 188 g (males); 140.8 to 142.5 g (females).
- Fasting period before study: No food was available on the night before the experiment. Water was given as needed.
- Housing: Makrolon cages (5 animals/cage)
- Diet (e.g. ad libitum): U.A.R. Réf. A03 15 mm pellets (daily ration, according to age and weight: 16 to 22 g); ad libitum
- Water (e.g. ad libitum): Water was acidified with hydrochloric acid (pH 2 - 3) and autoclaved for 15 minutes at 115°C; ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21
- Humidity (%): 55 to 60
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 25 mL/kg



Doses:
24.37 g/kg body weight [based on the dry weight of Lycasin® 80/55]
No. of animals per sex per dose:
Preliminary study: 5/sex/group
Main study: 10/sex/group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed frequently on the day of the experiment. During the following 13 days, mortality and the general aspect of the survivors were recorded. Each animal was weighed the day of the experiment and on Days 3, 7, 10, and 14.
- Necropsy of survivors performed: no

The authors noted that in the case of a death, the experiment would be redone on 20 other animals.
Statistics:
Statistical analysis was performed on body weight gain data.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: LD50 could not be determined.
Remarks on result:
other: Preliminary study: 2 deaths were reported (1/sex)
Sex:
male/female
Dose descriptor:
other: LD50 could not be determined.
Remarks on result:
other: Main study: No mortalities were reported during the study period.
Mortality:
Preliminary study: Two deaths (1/sex) were reported 24 hours following the forced feeding.
Main study: No mortalities were reported during the study period.
Clinical signs:
Preliminary study: No data.
Main study: None.
Body weight:
Preliminary study: No data.
Main study: The weight gain of the animals fed by oral route is comparable between the two groups.
Gross pathology:
Not examined.

Any other information on results incl. tables

The authors noted that in the case of a death, the experiment would be redone on 20 other animals. During the first trial, 2 deaths were observed, in which the authors attributed the deaths to a feeding error. The authors noted that the animals were nervous and a slightly bleedy nose was observed. No further details were available. Thus, the trial was repeated using the same methodology on a population of 10 animals per sex. The results discussed in this entry are based on the second (main) trial.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP EC 1272/2008