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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-08-04 to 1989-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant; Guideline Study (OECD 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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

Constituent 1
Details on test material:
- Physical properties: solid;
- Storage conditions: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF),
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited; Experimental Toxicology; 4332 Stein / Switzerland
- Age at study initiation: 6 to 8 weeks;
- Weight at study initiation:174 to 214 g;
- Fasting period before study: overnight,
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum;
- Water: tap water ad libitum;
- Acclimation period: at least 5 days;

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C;
- Humidity: 55 +/- 10 %.
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours dark/12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL;
- Amount of vehicle (if gavage): 10 mL;

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight;

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily; Weighing: on administration day, on day 7, and day 14;
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occurred in this study.
Clinical signs:
other: Pilolerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 4 days.
Gross pathology:
At autopsy, no deviations from normal morphology were found.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU