Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral in rats: LD50 = 3370±405 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel.2)

Acute toxicity, dermal in rabbits: 2500 mg/kg bw < LD50 < 5000 mg/kg bw (equivalent or similar to OECD 402, non-GLP, K, Rel. 2)

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Experimental conditions and detailed results are missing
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
None
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
None
Doses:
2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw
No. of animals per sex per dose:
No data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No data
Preliminary study:
Not applicable
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 370 mg/kg bw
Based on:
not specified
Remarks on result:
other:
Remarks:
±405 mg/kg bw
Mortality:
Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively.
Clinical signs:
Salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death
Body weight:
No data
Gross pathology:
No data
Other findings:
None

None

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.
Executive summary:

In an acute oral toxicity study, single oral doses of 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw of the test substance were given to groups of rats (no. not specified). Animals were then observed for mortality and clinical signs of toxicity for 14 days.

 

Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively. Clinical signs included salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death.

 

Rat Oral LD50 = 3370±405 mg/kg bw.

 

Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 370 mg/kg bw
Quality of whole database:
Adequate for hazard assessment

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

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Experimental conditions and detailed results are missing
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
None
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
None
Duration of exposure:
24 h
Doses:
5000 and 2500 mg/kg bw
No. of animals per sex per dose:
5/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: Mortality and dermal reactions.
- Necropsy of survivors performed: No
Statistics:
None
Preliminary study:
Not applicable
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 500 - < 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: indication of slight irritation at 24 h
Mortality:
5000 mg/kg bw: 3 deaths during the first day of observation
2500 mg/kg bw: no death throughout the observation period
Clinical signs:
No clinical signs of toxicity occurred during the study.
Body weight:
Not applicable
Gross pathology:
Not applicable
Other findings:
- Dermal reactions: 1 erythema was observed at 5000 mg/kg bw at 24 h.

None

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, the dermal LD50 of the test substance is 2500 mg/kg bw < LD50 < 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and is classified Category 5 according to the GHS.
Executive summary:

In an acute dermal toxicity study, 5 rabbits/dose were administered a single dermal dose of the test substance at 5000 and 2500 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.

3 deaths occured at 5000 mg/kg bw on the first day of the observation period. No mortality was observed throughout the observation period at 2500 mg/kg bw. No clinical signs of toxicity occurred during the observation period. Dermal reactions noted were limited to one erythema at 24 h at 5000 mg/kg bw.

Under the test conditions, the dermal LD50 of the test substance is 2500 mg/kg bw < LD50 < 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and is classified Category 5 according to the GHS.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

Acute toxicity: via oral route

In an acute oral toxicity study, single oral doses of 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw of the test substance were given to groups of rats (no. not specified). Animals were then observed for mortality and clinical signs of toxicity for 14 days.

Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively. Clinical signs included salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death.

Rat Oral LD50 = 3370±405 mg/kg bw.

Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.

Acute toxicity: via dermal route

In an acute dermal toxicity study, 5 rabbits/dose were administered a single dermal dose of the test substance at 5000 and 2500 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.

3 deaths occured at 5000 mg/kg bw on the first day of the observation period. No mortality was observed throughout the observation period at 2500 mg/kg bw. No clinical signs of toxicity occurred during the observation period. Dermal reactions noted were limited to one erythema at 24 h at 5000 mg/kg bw.

Under the test conditions, the dermal LD50 of the test substance is 2500 mg/kg bw < LD50 < 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and is classified Category 5 according to the GHS.

Justification for classification or non-classification

Harmonized classification:

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

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

- not classified according to the Regulation (EC) No. 1272/2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.

Acute toxicity via Dermal route:

Based on the available information, the registered substance is:

-not classified according to the Regulation (EC) No. 1272/2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.

Acute toxicity via Inhalation:This information is not available.

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.

Specific target organ toxicity: single exposure (Dermal):

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.

Specific target organ toxicity: single exposure (Inhalation): This information is not available.

Based on its composition (> 10% of aspiration toxicants or hydrocarbons), the registered substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.