Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From January 27 to February 19, 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The reliability of the source study is 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance
IUPAC Name:
Similar Substance

Test animals

Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd Biotechnology & Animal Breeding Division CH-44I4 Füllinsdorf / Switzerland
- Age at study initiation: Females: 10 weeks; Males: 8 weeks
- Weight at study initiation: Females: 170.7 - 176.9 g; Males: 222.1-226.7 g
- Fasting period before study:
- Housing: Groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4I32
Muttenz)
- Historical data:
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch nos. 31/98 (January 27 - February 2, 1999) 33198 (February 3-I9, 1999), rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to intubation)
- Water (e.g. ad libitum): Community tap water from ltingen, available ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): the room was illuminated by fluorescent light on a 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 m/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were examined for clinical signs four times during test day I and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15.
- Necropsy of survivors performed: yes, all animals were necropsied and examined macroscopically

Statistics:
No statistical analysis was used as no deaths occurred

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study
Clinical signs:
diarrhoea
Body weight:
lower than 10% body weight loss
Remarks:
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 2000 mg/kg b.w.
Executive summary:

Two groups, each using three female or three male Hanlbm: WIST (SPF) rats, were treated with Navy MGi 1319 at 2000 mg/kg by oral gavage according to the OECD guideline 423. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.
The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No death occurred during the study. In all animals, dark feces was observed until test day 2. In addition, all males and two females showed diarhea until 5 hours after treatment.
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
No macroscopic findings were observed at necropsy.
In conclusion the median lethal doseafter single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.was found to be greater than 2000 mg/kg body weight.