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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In an acute oral toxicity study in rat (EU method B.1, GLP) the LD50 was greater than 2000 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report. No restrictions, fully adequate for assessment
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to guideline
Guideline:
other: Acute Toxic Class Method (ATC Method) by E. Schlede, U. Mischke, R. Roll, D. Kayser: A National Validation Study of the Acute-Toxic-Class Method - An Alternative to the LD50 Test. Arch. Toxicol. 66: 455-470 (1992).
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GMBH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 150g - 300g (+- 20 % of the mean weight).
- Fasting period before study: at least 16 hours
- Housing: Single housing in stainless steel wire mesh cages, type DK-III (Becker & co., Castrop-Rauxel, FRG). No bedding in the cages.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum.
- Water: Tap water ad libitum
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12 ( 6.00 a.m. - 6.00p.m. / 6.00 p.m. - 6.00 a.m.)
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 gram per 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
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
- Bodyweight determination: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Recording of signs and symptoms: Several times on the day of administration, at least once each workday for the individual animals
- General observation and mortality: Twice each workday and once on Saterdays, Sundays and on public holidays for general observations and for any dead or moribound animals.
- Necropsy of survivors performed: yes, at the last day of the observation period. Withdrawal of food at least 16 hours before killing withe CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
other: Male animals: In all animals discoloured urine (orange) was observed on day 1 Female animals: All animals showed Impaired general state (H0 - H4), Dyspnoea (H0 - H4) and Piloerection (H1- H4). One animal showed signs of staggering (H0 - H3) and two animal
Gross pathology:
No pathologic findings noted
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this study the oral LD50 in male and female Wistar rats is above 2000 mg/kg bw.
Executive summary:

In a GLP compliant study performed according to EU method B.1, and modified according to the acute toxic class method, three Wister rats per sex were given a single oral dose of test material preparation in aqua bidest. at a dose level of 2000 mg/kg body weight. Signs of reaction to treatment noted in the female animals comprised impaired general state, dyspnea, staggering and twitching. In the male animals only orange discolored urine could be observed. The female animals appeared normal 1 day after application The expected body weight gain has been observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study (14 days). Under the conditions of this study the range of mortality after oral application was found to be greater than 2000 mg/kg body weight for male and female animals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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 a GLP compliant study performed according to EU method B.1, and modified according to the acute toxic class method, three Wister rats per sex were given a single oral dose of test material preparation in aqua bidest. at a dose level of 2000 mg/kg body weight (BASF 1994). Signs of reaction to treatment noted in the female animals comprised impaired general state, dyspnea, staggering and twitching. In the male animals only orange discolored urine could be observed. The female animals appeared normal 1 day after application The expected body weight gain has been observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study (14 days). Under the conditions of this study the range of mortality after oral application was found to be greater than 2000 mg/kg body weight for male and female animals.


Justification for selection of acute toxicity – oral endpoint
One acute oral toxicity study is available. This study is adequate for covering this endpoint

Justification for classification or non-classification

Based on oral LD50 in rats of greater than 2000 mg/kg bw, classification for acute oral toxicity of the test substance is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.