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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) was carried out. Groups of fasted young albino rats (5 male/5 female per dose group) were given a single oral dose (gavage) of 2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males was 4700 mg/kg bw (95% C.I. 4100 – 550 mg/kg bw) and females was 4300 mg/kg bw (95% C.I. 3900 – 4700 mg/kg bw). The LD0 obtained for males and females was 2000 mg/kg bw . The LD100 for males was 6300 mg/kg bw and for females 5000 mg/kg bw. The test item was considered practically non-toxic.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young
- Weight at study initiation: 200 -300 g
- Fasting period before study: 24 h
- Housing: Common cage
- Diet: Ad libitum
- Water: Ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs, body weight, organ weights, histopathology, other: None
Statistics:
No data.
Sex:
male
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
4 700 mg/kg bw
Based on:
test mat.
95% CL:
4 100 - 5 500
Sex:
male
Dose descriptor:
LD100
Effect level:
6 300 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
4 300 mg/kg bw
Based on:
test mat.
95% CL:
3 900 - 4 700
Sex:
female
Dose descriptor:
LD100
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
See table 1 and 2 below for details.
Clinical signs:
other: Male and female animals dosed at 2000 mg/kg bw and 4000 mg/kg bw were languid with unkempt coats. At the 5000 mg/kg bw dosage level, the animals were sluggish with ruffled unkempt coats after dosing. Commencing on the second day unsteady and staggering ga
Gross pathology:
No data.
Other findings:
None.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study groups of fasted young albino rats (5 male/5 female per dose group) were given a single oral dose (gavage) of 2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males was 4700 mg/kg bw (95% C.I. 4100 – 550 mg/kg bw) and females was 4300 mg/kg bw (95% C.I. 3900 – 4700 mg/kg bw). The LD0 obtained for males and females was 2000 mg/kg bw. The LD100 for males was 6300 mg/kg bw and for females 5000 mg/kg bw. The test item was considered practically non-toxic.
Executive summary:

A study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) was carried out. Groups of fasted young albino rats (5 male/5 female per dose group) were given a single oral dose (gavage) of 2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males was 4700 mg/kg bw (95% C.I. 4100 – 550 mg/kg bw) and females was 4300 mg/kg bw (95% C.I. 3900 – 4700 mg/kg bw). The LD0 obtained for males and females was 2000 mg/kg bw. The LD100 for males was 6300 mg/kg bw and for females 5000 mg/kg bw. The test item was considered practically non-toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 300 mg/kg bw

Additional information

Justification for classification or non-classification

Based on results obtained in acute toxicity testing the substance is not classified and labeled according to Regulation 1272/2008/EEC (CLP) and Directive 67/548/EEC (DSD).