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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The test substance did not cause any mortality up to a single oral dose of 15000 mg/kg bw. The oral LD0 and LD50 is higher than 15000 mg/kg bw. As the test substance is neither inhalable, nor likely to penetrate the skin due to its physico-chemical properties, further testing was not conducted.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
other: Tif:RAIf
Remarks:
Sprague-Dawley derived
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Weight at study initiation: 105 to 120 g
- Fasting period before study: overnight
- Housing: 5/cage
- Diet ad libitum: No 890 Nafag Gossau SG
- Water (e.g. ad libitum): tap
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 10/14

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% (1000 mg/kg), 30% (3000 mg/kg), 25% (10000 and 15000 mg/kg)
- Amount of vehicle (if gavage): 10 ml/kg (1000 and 3000 mg/kg), 40 ml/kg (10000 mg/kg), 60 ml/kg (15000 mg/kg)
Doses:
1000, 3000, 10000, 15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of weighing: Days 1 and 15
- Clinical signs and mortality: throughout observation period
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 15 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: 1000 mg/kg bw: none 3000 mg/kg bw: reduction in spontaneous motility, ataxia, muscular hypotonia with partial hypertonia, hyperreflexia. After 3 days no symptoms 10000 mg/kg bw: reduction in spontaneous motility, ataxia, muscular hypotonia with partial hy
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not cause any mortality up to 15000 mg/kg bw. The LD0 and LD50 is higher then 15000 mg/Kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification