Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 oral acute LD50 was determined to be greater than 2500 mg/kg bw in rats.

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:
2001-09-13 and 2001-11-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-conform study according to OECD guideline and EU method
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approximately eight weeks
- Weight at study initiation: at least 200g
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum with exception of the fasting period
- Water: ad libitum with exception of the fasting period
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.14 mL/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and signs of toxicity were observed 30, 60, 120 and 240 min after dosing and subsequently once daily for fourteen days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
other: Common signs of systemic toxicity noted during the day of dosing were hunched posture, lethargy and ataxia. Hunched posture was noted in all females one day after dosing. Males appeared normal one day after dosing and females appeared normal two days afte
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 value of the test material in rats was estimated to be greater than 2500 mg/kg bw.
Executive summary:

In an oral acute toxicity study, six fasted Sprague-Dawley (3 male and 3 female) rats were orally exposed once with the test substance at a concentration level of 2000 mg/kg bw and were observed for a period of 14 days (OECD 423). No deaths and abnormalities at necropsy were observed. All animals showed expected gains in bodyweight over the study period. Signs of systemic toxicity were hunched posture, lethargy and ataxia, however disappeared during the observation period. The LD50 value of the test material was estimated to be greater than 2500 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
GLP-conform study, according to OECD guideline and EU method

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

In an oral acute toxicity study, six fasted Sprague-Dawley (3 male and 3 female) rats were orally exposed once with the test substance at a concentration level of 2000 mg/kg bw and were observed for a period of 14 days (OECD 423). No deaths and abnormalities at necropsy were observed. All animals showed expected gains in bodyweight over the study period. Signs of systemic toxicity were hunched posture, lethargy and ataxia, however disappeared during the observation period. The LD50 value of the test material was estimated to be greater than 2500 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one reliable study available.

Justification for classification or non-classification

The available data gave no indications for acute toxic properties of the test substance via oral route. On the basis of these data the substance is not considered to be classified for oral acute toxicity under Regulation (EC) No 1272/2008 (CLP).