Registration Dossier

Administrative data

Description of key information

The acute toxicity of the test material was investigated, by the (i) oral and (ii) inhalation routes, in studies which were conducted under GLP conditions and in accordance with the standardised guideline EU (i) Method B.1. and (ii) Annex V.

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:
guideline study
Justification for type of information:
The study was performed according to a valid guideline without any deviations and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the information, which has been extracted from the ECHA databases, for REACH registration purposes. No full information related to the experimental result are available but these deficiencies do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
other: Carboxymethyl Cellulose Sodium
Details on oral exposure:
no data
Doses:
no data
No. of animals per sex per dose:
5 animals/sex/group
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Preliminary study:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No deaths occurred. No significant changes were observed.
During the 14-day observation period, only mild soft stools were observed in one male rat from 50 minutes to 3 hours after the administration, and in one female rat at 3 hours after the administration.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study period.
Other findings:
no data

no data

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of the test material was determined to be > 2000 mg/kg bw.
The substance is not classified, in accordance to CLP criteria.
Executive summary:

Under the conditions of the study, the LD50 of the test material was determined to be > 2000 mg/kg bw. The substance is not classified, in accordance to CLP criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was performed according to a valid guideline without any deviations and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the information, which has been extracted from the ECHA databases, for REACH registration purposes. No full information related to the experimental result are available but these deficiencies do not affect the quality of the relevant results.
According to Column 2 of Section 8.5 of Annex VIII details specific rules for adaptation, notably requiring information on at least one other route of exposure depending on the nature of the substance and the likely route of human exposure.
Considering the chemico-physical characteristics of the substance and the likely route of human exposure, it was judged as priority and essential to submit information related to acute toxicity by inhalation route.
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
no data
No. of animals per sex per dose:
5 animals/sex/group
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Preliminary study:
no data
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.9 mg/L air
Based on:
not specified
Exp. duration:
4 h
Mortality:
Male: 1.9 mg/L; Number of animals: 5; Number of deaths: O
Female: 1.9 mg/L; Number of animals: 5; Number of deaths: O
Clinical signs:
other: Signs of toxicity related to dose levels: No deaths occurred. Clinical signs of nasal discharge, ocular discharge and ruffled fur occurred alter exposure and persisted for several days. There were no other visible effects.
Body weight:
no data
Gross pathology:
Effects on organs:
Necropsy findings revealed no gross lesions or abnormalities of any kind.
Other findings:
no data

no data

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of the test material was determined to be > 1.9 mg/L air (4h): the substance is not classified, in accordance to CLP criteria.
Executive summary:

Under the conditions of the study, the LD50 of the test material was determined to be > 1.9 mg/L air (4h): the substance is not classified, in accordance to CLP criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
19 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
Column 2 of Section 8.5.3 of Annex VIII further allows for the waiving of acute dermal toxicity testing if (i) the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route and (ii) no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non - testing approaches (e.g. read across, QSAR studies).

The substance of interested does not meet the criteria for classification for acute toxicity or STOT Se by the oral route, he substance is not corrosive or sensitising to the skin.

On the other hand, the inhalation route was judged as the more likely route of human exposure considering the (i) uses and (ii) chemico-physical properties of the substance.
Executive summary:

The skin contact is unlikely and the physicochemical and toxicological properties suggest low potential for significant rate of absorption through the skin.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

no data

Justification for classification or non-classification

Justification for selection of acute toxicity – oral endpoint
Under the conditions of the reported study, the LD50 of the test material was determined to be > 2000 mg/kg bw: the substance is not classified, in accordance to CLP criteria.

Justification for selection of acute toxicity – inhalation endpoint
Under the conditions of the reported study, the LD50 of the test material was determined to be > 1.9 mg/L air (4h): the substance is not classified, in accordance to CLP criteria

Justification for selection of acute toxicity – dermal endpoint
data waiving