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Description of key information

Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.2, 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:
From 24 January to 8 February 2012.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP study conducted in compliance with OECD Guideline No. 423 without any deviation. The substance is adequately identified, but some data on composition is missing. Therefore validation applies with restrictions.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001.
Deviations:
no
Qualifier:
according to guideline
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. QA statement)
Remarks:
Inspected on 2010-12-07 / Signed on 2011-03-07.
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
- Physical state: Colourless gel
- Date received: 13 January 2012
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 183 - 211 g
- Housing: housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff (M20, SDS), ad libitum but food was removed at D-1 and then redistributed 4 hours after the test item administration.
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70%
- Air changes: between ten and fifteen changes per hour.
- Photoperiod: 12 h light/12 h darkness.

IN-LIFE DATES: From 24 January to 8 February 2012.

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.08 mL/kg bw

ADMINISTRATION OF TEST ITEM:
Animals received an effective dose of 2000 mg/kg bw of the test item, administered by force-feeding under a volume of 2.08 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min, 1, 3 and 4 hours after test item administration and thereafter once daily for 14 days. Animals were weighed pretest (Day 0) and on Day 2, 7 and 14.
- Necropsy of survivors performed: Yes; Animals were killed on Day 14 and subjected to macroscopic examination.
Statistics:
None
Preliminary study:
Not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: Mydriasis (6/6) was noted during the first hours of the test. No clinical signs related to the administration of the test item were observed from 24 hours post dose.
Gross pathology:
The macroscopical examination of the animals at the end of the study revealed the presence of a white thickening forestomach (2/6).
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 Female > 2000 mg/kg bw. Under the test conditions, the test material is not classified according to the annex I of the Regulation (EC) No. 1272/2008 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 undiluted test item at 2000 mg/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. Mydriasis (6/6) was noted during the first hours of the test. The animals recovered a normal behaviour at 24 hours post-dose. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study revealed the presence of a white thickening forestomach (2/6).

 

Oral LD50 Female > 2000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex I of the Regulation (EC) No. 1272/2008 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
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is GLP compliant and of high quality (Klimisch score was lowered to 2 because of missing information regarding the identification of the substance)

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

Acute toxicity: oral

A key study was identified (Phycher, 2012, rel. 2). In this acute oral toxic class method study performed according to the OECD guideline No. 423 and in compliance with GLP, six female Sprague Dawley rats received a single oral (gavage) dose of the test substance at a dose level of 2000 mg/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 significant clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study.The macroscopical examination of the animals at the end of the study revealed the presence of a white thickening forestomach (2/6).

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 (CLP).


 


Self classification:


Acute toxicity (Oral):


Based on the available information, the substance is:


- not classified according to the 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 CLP and to the GHS 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 the CLP or the GHS 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.


 


Aspiration hazard:


The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.