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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity: A primary oral toxicity study (Beerens-Heijnen, 2010) was available which is key study. This study showed that the oral LD50 value of test substance is established to exceed 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 03 to 29 September 2010
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
Test type:
acute toxic class method
Limit test:
other: Wistar strain Crl:WI (Han) (outbred, SPF-Quality)
Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Approx. 8 weeks old
- Weight at study initiation: Bodyweight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days

- Temperature (°C): 21.0 ± 3.0ºC (actual range: 19.6 – 21.6ºC)
- Humidity (%): A relative humidity of 40-70% (actual range: 42 - 75%)
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

IN-LIFE DATES: From: 03 September 2010 To: 29 September 2010
Route of administration:
oral: gavage
other: 1% Aqueous carboxymethyl cellulose
Details on oral exposure:
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
- Lot/batch no. (if required):
- Purity: 1% w/v
2000 mg/kg (10 mL/kg) body weight
No. of animals per sex per dose:
3 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability Twice daily. Body weights Days 1 (pre-administration), 8 and 15. Clinical signs At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes. At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
None stated
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortality occurred.
Clinical signs:
other: Hunched posture and/or piloerection were noted in all animals on Day 1.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The oral LD50 value of this substance in Wistar rats was established to exceed 2000 mg/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
2 000 mg/kg bw
Quality of whole database:
1 (reliable without restriction)

Additional information

Acute oral toxicity:

A primary oral toxicity study was conducted according to OECD 423 using rat (Beerens-Heijnen, 2010). Key study.

This study showed that the oral LD50 value of test substance is established to exceed 2000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
Study run to a method comparable with current guidelines and to GLP

Justification for classification or non-classification

Oral LD50 = >2,000 mg/kg (actual value >2,000 mg/kg)

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is not classified for the acute toxicity endpoint.