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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Remarks:
Crl: CD.BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Five to seven weeks old
- Weight at study initiation: Males 163 to 188 g and females 145 to 162 g
- Fasting period before study: Yes (18 hours prior to dosing until 3 hours after dosing).
- Housing: Up to 5 rats of the same sex were accommodated in suspended stainless steel mesh cages.
- Diet (e.g. ad libitum): SQC(E) rat and mouse maintenance diet No. 1 was freely available to the animals at all times except for a period of fasting.
- Water (e.g. ad libitum): Mains water was provided ad libitum via cage mounted water bottles.
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 40 to 70% relative humidity
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: standard vehicle

MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg

DOSAGE PREPARATION (if unusual): The test article was dispersed in corn oil and all formulations were used on the day of preparation.
Doses:
Preliminary test: 500 and 2000 mg/kg
Main test: 2000 mg/kg
No. of animals per sex per dose:
Five males and five females in the main phase
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were noted once within 30 minutes of dosing, four times within the first 4 hours of dosing, twice daily on days 2, 3 and 4 then once daily from the 5th onwards. Bodyweights were recorded on day -1, Day 1, 8 and 15.
- Necropsy of survivors performed: yes. The necropsy procedure included inspection of external thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines.
- Other examinations performed:
Statistics:
Not required
Preliminary study:
Groups of one fasted female rat dosed at 500 or 1000 mg/kg/day. All animals survived.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died following a single oral dose.
Clinical signs:
other: Two males were lethargic approximately four hours after dosing on Day 1 but this had resolved by day 2. Staining of teh snout was apparent in all rats during Day 2 and the female rats also showed soiling of the anogenital region.
Gross pathology:
Necropsy at termination revealed enlargement or red foci on the mandibular lymph nodes of 5 rats, reddening of the thymus in two rats and single cases of a small uterus or renal pelvic dilatation.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute median lethal oral dose of the test substance to rats was found to exceed 2000 mg/kg (the standard limit dose for such studies).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Reliable study available

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

In the available acute oral toxicity study, no deaths were noted at the limit dose of 2000 mg/kg. Accordingly the substance is not classified for acute toxicity effects in accordance with the CLP regulation (EC No. 1272/2008).