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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The acute oral LD50 value was found to be >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
Study period:
1990-11-26 to 1990-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D 269
- Expiration date of the lot/batch: December 1989
- Purity test date: 1990-07-16

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 20 °C in fume cupboard
- Stability under test conditions: stable


Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 182 - 190 g (males); 178 - 181 g (females)
- Age at study initiation: males appr: 7 weeks, females appr. 8 weeks
- Fasting period before study: 16 hours before application
- Housing: in groups of 5 in macrolon cages
- Diet: ad libitum (Altromin 1324)
- Water: ad libitum (tap water)
- Acclimation period: not necessary as breeding under identical conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test item was diluted in water (with a magnetic stirrer) to a concentration of 20 % (w/v).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopically examinations
Statistics:
Not necessary as no mortality occured.
Preliminary study:
No details on preliminary study.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: Clinical signs were not observed in male or female rats.
Gross pathology:
No macroscopically visible changes were found.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of the test item was determined to be > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five wistar rats of each sex were exposed to the test item by oral gavage at a limit dose of 2000 mg/kg bw. The animals were observed for 14 days. No mortality occured and no signs of systemic toxicity were observed. The body weight was not affected. No macroscopic changes were noticed at necropsy. Therefore, the LD 50 was determined to be >2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and Guideline study

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

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five wistar rats of each sex were exposed to the test item by oral gavage at a limit dose of 2000 mg/kg bw. The animals were observed for 14 days. No mortality occured and no signs of systemic toxicity were observed. The body weight was not affected. No macroscopic changes were noticed at necropsy. Therefore, the LD 50 was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) 1272/2008 (CLP). As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.