Registration Dossier

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)

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:

other: Salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death

Gross pathology:

No data

Other findings:

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:

adverse effect observed

Dose descriptor:

LD50

Value:

3 370 mg/kg bw

Quality of whole database:

Adequate for hazard assessment

Reference

Endpoint:: acute toxicity: inhalation
Data waiving:: other justification
Justification for data waiving:: other:

Endpoint conclusion:

no study available

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:

other: No clinical signs of toxicity occurred during the study.

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:

adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

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.

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.