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Toxicological information

Acute Toxicity: oral

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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 April 19 to May 3, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
In two males the allowed initial body weight was exceeded by 2 and 3 g, respectively.
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif : RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 182 to 243 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were housed in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: at least for 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Volume applied: 10 ml/kg body weight
Doses:
2000 mg/kg (males and females)
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- 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; - Body weight: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes, The animals were submitted to a gross necropsy at the end of the observation period.

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 occurred in this study
Clinical signs:
Pilerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days.

Any other information on results incl. tables

Necropsies

At necropsy, no deviations from normal morphology were found in all animals.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Method:

The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401 and EU Method B.l.

Observations:

Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days. At necropsy, no deviations from normal morphology were found in all animals.

Results:

LD50 > 2000 mg/kg bw