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Administrative data

Description of key information

Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats)

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:
21 March to 05 April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted in compliance with OECD Guideline No. 423 with minor deviations: age at study initiation, housing and feeding conditions, details of fasting not reported. These deviations do not affect the quality of the study and are not considered to be relevant.
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
age at study initiation, housing and feeding conditions, details of fasting not reported
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
13 December 2005
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Elevage JANVIER (53940 Le Genest St Isle, France.- Weight at study initiation: 208-228 g- Fasting period before study: No data- Housing: No data- Diet: No data- Water: No data- Acclimation period: 5 days ENVIRONMENTAL CONDITIONS - Temperature: 21-23 °C - Humidity: 38-60 % IN-LIFE DATES: 21 March to 05 April 2006
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
ADMINISTRATION: Animals received an effective dose of 2000 mg/kg bw of the test item, administered by force-feeding under a volume of 1.95 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.MAXIMUM DOSE VOLUME APPLIED: 1.95 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations: Clinical observations were performed 30 minutes, 1, 3 and 4 h after test substance administration, and once daily thereafter for 14 days. - Frequency of weighing: Body weights were observed on Days 0, 2, 7 and 14.
Statistics:
None
Preliminary study:
Not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred during the study.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw administered by force-feeding under a volume of 1.95 ml/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No clinical signs related to the administration of the test substance were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. In this study, the oral LD50 of test substance was considered to be higher than 2000 mg/kg bw in female rats.

 

Under the test conditions, the test substance is not classified for acute oral toxicity according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The key study is GLP compliant and of high quality (Klimisch score = 1)

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

A key study was identified (Phycher, 2006, rel. 1). In this acute oral toxic class method study performed according to the OECD guideline No. 423 and in compliance with GLP, six fasted female rats received a single oral gavage dose of the test substance at a dose level of 2000 mg/kg bw, administered by force-feeding under a volume of 1.95 ml/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No clinical signs related to the administration of the test substance were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Oral LD50 > 2000 mg/kg bw

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Acute toxicity (Oral):

Based on the available information, the substance is:

- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw

- not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).

Acute toxicity (Dermal):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

Acute toxicity (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

Specific target organ toxicity: single exposure (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level..