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

Acute Toxicity: dermal

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Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Yellowish Brown Liquid, Lot # 00312AB, no purity given

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.