Tripropylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented publication which meets basic scientific principles

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Penetration of rabbit skin is estimated by a technique closely akin to the one-day cuff method of Draize and associate. No information is on test animals and their environmental conditions as well as health state after the treatment.

GLP compliance:

no

Remarks:

the study was conducted prior adoption of GLP

Test type:

other: penetration on rabbit skin

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tripropylamine

EC Number:

203-047-7

EC Name:

Tripropylamine

Cas Number:

102-69-2

Molecular formula:

C9H21N

IUPAC Name:

tripropylamine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tripropylamine
- Substance type: organic
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0-3.5 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: entire trunk
- Type of wrap if used: imperious plastic film
The animals were immobilized during the exposure.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data; Dosages greater than 20 mL/kg could not be retained in contact with the skin.

Duration of exposure:

24 hours

Doses:

No data

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data

Statistics:

Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures' in parentheses show limits of ± 1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

430 mg/kg bw

Based on:

test mat.

Remarks:

0.57 mL/kg bw

Remarks on result:

other: (0.26-1.23), the dose is calculated based on density of 0.7557 g/cm³

Mortality:

No data

Clinical signs:

other: other: No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information GHS Criteria used for interpretation of results: EU

Conclusions:

LD50 of 0.57 mL/kg bw (corresponding to 430 mg/kg bw) was reported for tripropylamine. According to Regulation (EC) No 1272/2008, tripropylamine should be classified in Cat 3 as acute toxic substance by dermal route (H301 Toxic in contact with skin).

Executive summary:

Tripropylamine was tested in a range-finding toxicity study in New Zealand rabbits (Smyth et al., 1969). Penetration of rabbit skin is estimated by a technique closely akin to the one-day cuff method of Draize and associates using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. Based upon mortalities during 14 -day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil (references are cited in the publication). LD50 of 0.57 mL/kg bw (range 0.26 - 1.23) was reported for tripropylamine. The range shows limit of± 1.96 standard deviation. Based on the density of 0.7557 g/cm³ (Lechte, 2010), 0.57 mL/kg bw corresponds to 430 mg/kg bw.