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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity: Based on a study performed according to OECD TG 401, the LD50 (rat) > 5000 mg/kg bw.

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:
2007-05-16 to 2007-05-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute 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: Harlan Sprague-Dawley, Indianapolis, Indiana, USA
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 204 - 225g
- Fasting period before study: overnight
- Housing: individually in stainless steel caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64-79°F
- Humidity (%): 30-70%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 hour light:dark cycle

IN-LIFE DATES: From: 2007-05-16 To: 2007-05-30
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.0 g/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations: Day 1 1, 2 and 4 hours after dosing then once daily
Weight: At study initiation and on days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
If significant mortality occurs calculation of LC50 and 95% confidence intervals may be performed using the method of moving averages and the tables constructed by Weil (1952)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed
Clinical signs:
No clinical signs noted.
Body weight:
No treatment related effect on bodyweight noted.
Gross pathology:
No treatment related effects noted.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The administration of the test material by oral gavage at a dose of 5000 mg/kg bw to Sprague-Dawley rats (5 male/5 female) produced no mortalities or other indication of treatment related effects. The LD50 was determined to be > 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of the neat test material was assessed in male and female rats in accordance to OECD Guideline No. 401, and US EPA OPPTS 870.1100. Five male and five female rats were dosed by oral gavage with 5000 mg/kg bw. After a 14 day observation period there were no mortalities. There were no treatment related effects observed on bodyweight or at gross necropsy. The LD50 was > 5000 mg/kg bw.

In accordance with Regulation (EC) No. 1272/2008 the substance is not classified for acute toxicity by the oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
Good - 1 k=1 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

Acute oral toxicity

The acute oral toxicity of the substance was assessed in male and female rats in accordance to OECD TG 401 and US EPA OPPTS 870.1100. Five male and five female rats were dosed by oral gavage at 5000 mg/kg bw. After a 14 day observation period there were no mortalities. There were no treatment-related effects observed on bodyweight or at gross necropsy. The LD50 was > 5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
k=1 study performed on the substance

Justification for classification or non-classification