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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1991-12-20 to 1992-03-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study (OECD 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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

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 Animal Production; 4332 Stein / Switzerland;
- Initial body weight range: 173 to 195 g
- Husbandry: rats were kept in an animal room under conventional laboratory conditions
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle.
- Air changes (per hr): approximately 15 air changes per hour)
- Temperature: 22 +/- 2 °C
- Relative humidity: 55 +/- 10 %
- Housing: the rats were individually housed in Macrolon cages type 3, with standardized soft wood bedding
- Acclimatisation: rats were acclimatized for at least 5 days before exposure
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) and water were provided ad libitum

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:
- Volume applied: 10 mL/kg bw
Doses:
2000 mg/kg bw (males and females)
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Observation period: 14 days
- Prior to dosing, the animals were fasted overnight
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Weighing: on day 0, 7, and 14
- Necropsy of survivors performed: yes


Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed during the observation period
Clinical signs:
other: Piloerection, hunched posture, dyspnea
Gross pathology:
No observable abnormalities
Other findings:
All animals recovered within 3 days

Applicant's summary and conclusion

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