Registration Dossier

Administrative data

Description of key information

Acute oral: The acute oral LD50 was determined to be greater than 2000 mg/kg bodyweight.
Acute inhalation: The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.
Acute dermal: The acute dermal LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
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:
Wistar strain Crl:(WI) BR
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females at 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.

Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred at 2000 mg/kg.
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:
No clinical signs of toxicity were observed.
Gross pathology:
Effects on organs: No abnormalities were found in the animals at macroscopic post mortem examination.
Other findings:
None.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.
Executive summary:

Acute oral

The test substance was assessed for acute oral toxicity according to EU Method B1.

No mortality occurred at 2000 mg/kg and no clinical signs of toxicity were observed. No abnormalities were found in the animals at macroscopic post mortem examination. 

The acute oral LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Study conducted in accordance with generally accepted scientific principles and guidelines.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
Mass median aerodynamic diameter of test substance: 2.8 µm
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
5.08 mg/L air
No. of animals per sex per dose:
5 males and 5 females at 5.08 mg/L
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.08 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality at 5.08 mg/L air.
Male: 5.08 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.08 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Clinical signs during exposure consisted of a slightly decreased breathing rate in all animals that developed in severity from slight in the first hour to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure consisted of a decreased breathing rate, piloerection, hunched posture, blepharospasm and sluggishness, all to a moderate degree.

During the first day of the observation period sluggishness could still be seen in 3/5 males and in all females and ruffled fur was noted in 2/5 male and in all females. Less frequent findings on the first day consisted of solid fur, encrustations around eyes, nasal encrustations and grunting respiration. In the remainder of the 14-day observation period (day 2-14) no exposure-related observations were seen.
Gross pathology:
Effects on organs: Abnormalities at necropsy were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.
Other findings:
None.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.
Executive summary:

The test substance was assessed for acute inhalation toxicity according to OECD 403. 

No mortality occurred at 5.08 mg/L air. Dose-related signs of toxicity included a slightly decreased breathing rate in all animals that developed in severity, from slight in the first hour, to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure included a decreased breathing rate and sluggishness. The sluggishness continued during the first day and some rats were observed to have grunting respiration. In the remainder of the 14-day observation period no exposure-related observations were seen. At necropsy, abnormalities were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.

The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Study conducted in accordance with generally accepted scientific principles and guidelines.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
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:
Wistar strain Crl:(WI) BR
Type of coverage:
semiocclusive
Vehicle:
corn oil
Duration of exposure:
24 hour
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females at 2000 mg/kg bw.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.

The test sites were examined for evidence of primary irritation and scored according to the Draize scale.

Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred at 2000 mg/kg.
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 abnormalities found.
Gross pathology:
Effects on organs: No abnormalities were found in the animals at macroscopic post mortem examination.
Other findings:
Signs of toxicity (local):
No clinical signs of local toxicity (irritation) were observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.
Executive summary:

The test substance was assessed for acute dermal toxicity according to EU Method B3. 

No mortality occurred at 2000 mg/kg. There were no signs of toxicity related to dose levels during the 14 day observation period, and no abnormalities were found in the animals at macroscopic post mortem examination. 

The acute dermal LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Study conducted in accordance with generally accepted scientific principles and guidelines.

Additional information

Acute oral

The test substance was assessed for acute oral toxicity according to EU Method B1. 

No mortality occurred at 2000 mg/kg and no clinical signs of toxicity were observed. No abnormalities were found in the animals at macroscopic post mortem examination. 

The acute oral LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.

 

Acute inhalation

The test substance was assessed for acute inhalation toxicity according to OECD 403. 

No mortality occurred at 5.08 mg/L air. Dose-related signs of toxicity included a slightly decreased breathing rate in all animals that developed in severity, from slight in the first hour, to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure included a decreased breathing rate and sluggishness. The sluggishness continued during the first day and some rats were observed to have grunting respiration. In the remainder of the 14-day observation period no exposure-related observations were seen. At necropsy, abnormalities were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.

The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.

 

Acute dermal

The test substance was assessed for acute dermal toxicity according to EU Method B3. 

No mortality occurred at 2000 mg/kg. There were no signs of toxicity related to dose levels during the 14 day observation period, and no abnormalities were found in the animals at macroscopic post mortem examination. 

The acute dermal LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.


Justification for selection of acute toxicity – oral endpoint
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for use for the substance being registered.

Justification for selection of acute toxicity – inhalation endpoint
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for use for the substance being registered.

Justification for selection of acute toxicity – dermal endpoint
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for use for the substance being registered.

Justification for classification or non-classification

Based on acute oral and acute dermal LD50 values of > 2000 mg/kg bw and the acute inhalation LD50 of 5.08 mg/L the test substance is not classified in accordance with the criteria outlined in Regulation (EC) 1272/2008/EC (CLP) or Directive 67/548/EEC (DSD).