3,5-diethyl-1,2-dihydro-1-phenyl-2-propylpyridine

Endpoint summary

Description of key information

Oral LD50 > 500 mg/kg bw, dermal LD50 > 1000 mg/kg bw

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:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

equivalent or similar to guideline

Guideline:

other: U.S. 52 FR 42961, 49 CFR 173.132

Principles of method if other than guideline:

This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Albino rats, five males and five females
All weighed between 200 and 300g

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

All rats were administered a single Sponsor specified dose of the test substance by oral gavage.

Doses:

500 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

All animals received a single dose of 500 mg/kg bw of the test substance by oral gavage. The dose volume did not exceed 1 ml/100 g body weight. Following treatment, the animals were observed for clinical signs of toxicity at least once daily for 14 days. Body weights were determined on Day 0, Day 7, and Day 14.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

test mat.

Mortality:

1 rat died on Day 2 of the observation period.

Clinical signs:

other: Two of the test animals exhibited clinical signs

Gross pathology:

The animal that died during the study was observed at necropsy as having a moderately pale liver. All other animals were observed as having no visible lesions at necropsy

The oral LD50 of the test material is ≥500 mg/kg bw according to a U.S. DOT guideline study.

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

> 300 mg/kg as per Regulation EC No. 1272/2008

Conclusions:

The oral LD50 of the test material is greater than 500 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Quality of whole database:

adequate

Acute toxicity: via inhalation route

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:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

equivalent or similar to guideline

Guideline:

other: U.S. 52 FR 42961, 49 CFR 173.132

Principles of method if other than guideline:

This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Ten albino ratts (5 male and 5 female) were used in the study

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dorsums were clipped free of hair prior to application of the test article. The test article was introduced to not less than 10% of the total body surface area (15.5cm x 15.5cm) The test article was held in contact with the skin with prous gauze dressing and non-irritating tape. The animals were further wrapped with Vetrap bandaging for the exposure period.

Duration of exposure:

24 hours

Doses:

1000 mg (1 g)/kg bw, as specified by sponsor

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

The duration of the occlusive exposure was 24 hours. At the end of the exposure period, the test sites were rinsed with water and the animals observed for signs of erythema and edema. The animals were then observed daily for clinical signs of toxicity for a 14 day observation period. At the end of the observation period, a gross necropsy was performed on all animals.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

The LD50 may be > 2000 mg/kg bw

Mortality:

None observed

Clinical signs:

other: No signs of toxicity were observed in any of the animals. However, erythema was noted on all animals after the 24h exposure period and was reversed on all animals by Day 5.

Gross pathology:

No unusual observation recorded in gross pahtologies.

Erythema was noted on all animals after the 24h exposure period, but resolved in all animals by day 5.

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the test material is > 1000 mg/kg bw, with no observed lethality for 14 days after exposure. This was evaluated as "non-toxic" according to the U.S. DOT guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Quality of whole database:

adequate

Justification for classification or non-classification

The substance has an oral LD50 > 500 mg/kg bw; this meets the criteria for classification as acute oral toxicity 4 (300 mg/kg > LD50 < 2000 mg/kg). The dermal LD50 is > 1000 mg/kg bw and evaluated as "non-toxic" with lethality reported, though this single dose is not sufficiently high to meet GHS requirements for non-classification. Due to the absence of any animal deaths at 1000 mg/kg bw, and the evaluation of "non-toxic" according to U.S. DOT guidance, the substance is not classified for acute toxicity by the dermal route. However, due to an indication of skin irritation and severe damage to the eye, protection from dermal exposure is recommended by the use of personal protective equipment.