Registration Dossier

Administrative data

Description of key information

The oral LD50 in rats is between 300 and 2000 mg/kg bw (RL1).

The acute inhalation study was waived in accordance with Column 2 of REACH Annex VIII No. 8.5, as acute toxicity studies do not need to be conducted when the substance is classified for skin corrosion (H314).

The acute dermal study was waived in accordance with Column 2 of REACH Annex VIII No. 8.5, as acute toxicity studies do not need to be conducted when the substance is classified for skin corrosion (H314).

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:
From 02 JUL 2002 to 26 AUG 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17-12-2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Remarks:
Hsd:Sprague Dawley (SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 178 -200 g
- Housing: in transparent macrolon® cages (type IV) on soft wood granulate* in an air-conditioned room, 3 animals per cage
- Diet: ssniff® RIM-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 7.14 % (w/v) and 47.62 % (w/v)
The test item was dissolved in the stated concentrations in deionized water and distributed homogeneously by means of a magnetic stirrer. The high dose was administered undiluted. The stability and the homogeneity of the test substance in the vehicle was guaranteed by the sponsor.
Doses:
714 and 4762 mg/kg bw based on the test material containing 42 % C Quart.
Calculated to the amount of C Quart, 300 and 2000 mg/kg bw were applied.
No. of animals per sex per dose:
6 animalsin the lower dose group, 3 in the higher
Control animals:
no
Details on study design:
The observation period following treatment lasted for 14 days. Symptoms and lethality were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. Animals found dead were dissected as soon as possible and examined for macroscopically visible changes. At the end of the observation period surviving animals were killed by carbon dioxide asphyxiation, dissected and also examined for macroscopically visible changes.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
300 mg/kg bw; Number of animals: 6; Number of deaths: 0
2000 mg/kg bw; Number of animals: 3; Number of deaths: 3, during the study all animals in the highest dose group died.
Clinical signs:
These clinical symptoms were observed:

prone position, hyper activity, stupor, uncoordinated and ataxic gait, irregular respiration, panting, drawn in flanks as well as tonoclonic convulsions.

In the lower dose group no effects were observed.
Body weight:
Body weights were not affected by the test substance.
Gross pathology:
Effects on organs:

The animals in the highest dose group showed stomach filled with dark red mucous mass. The stomach of two animals was diffuse reddened and the mucuos membrane was detached. The forestomach of the third animal was also diffuse reddened.
The small intestine of all animals was diffuse reddened, additionally the small intestine of two animals was filled with mucous mass (one yellow the other one dark red). The mucous membrane was detached in both animals.

Furthermore, the lobus sinister of the liver of two animals was beige discolored.

The animals (low dose group) killed at the end of the observation period showed no macroscopically visible changes.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 (oral) of the substance is between 300 and 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 with female Spague-Dawley rats. In the low dose group (300 mg/kg bw) no effects and no mortalities were observed. In the high dose group (2000 mg/kg bw) all three animals died. Substance concentrations are based on active ingredient. As a result of the study, the LD50 (oral) was determined to be > 300 and < 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
300 mg/kg bw
Quality of whole database:
The key study is reliable without restrictions

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The acute inhalation study was waived in accordance with Column 2 of REACH Annex VIII No. 8.5, as acute toxicity studies do not need to be conducted when the substance is classified for skin corrosion (H314).

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The acute dermal study was waived in accordance with Column 2 of REACH Annex VIII No. 8.5, as acute toxicity studies do not need to be conducted when the substance is classified for skin corrosion (H314).

Additional information

Justification for classification or non-classification

The submission substance has to be classified for acute oral toxicity Cat. 4 (H302) according to Regulation (EC) No. 1272/2008 (CLP).