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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
March 29, 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing procedures

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Tif:MAGf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: CIBA-GEIGY breeding unit- Age at study initiation: 6 to 7 weeks old- Weight at study initiation: 160 to 180 g- Fasting period before study: The rats were starved during one night before starting the treatment.- Housing: Macrolon cage (Type 3) in groups of 5.- Diet: They received food (NAFAG, Gossau SG, rat food) ad libitum.- Water: ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1 °C- Humidity (%): 50%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE- Concentration in vehicle: The substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 10 % with carboxymethyl-cellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
1470, 2150, 3170 mg/kg
No. of animals per sex per dose:
5 x sex x doses
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 170 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 3 170 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 232 mg/kg bw
Based on:
act. ingr.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not classified according to CLP Regulation (EC n. 1272/2008)
Conclusions:
The LD50 is greater than 2232 mg/kg.
Executive summary:

The acute oral LD50 of test item in rats of both sexes observed over a period of 7 days is greater than 2232 mg/kg. The compound

has therefore a slight acute toxicity to the rat by this route of administration. The substance is not toxic according to the CLP Regulation (EC n. 1272/2008)