(2-hydroxypropyl)trimethylammonium formate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 18, 1976 - December 29, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2-hydroxypropyl)trimethylammonium formate

EC Number:

263-503-6

EC Name:

(2-hydroxypropyl)trimethylammonium formate

Cas Number:

62314-25-4

Molecular formula:

C6H16NO.CHO2

IUPAC Name:

(2-hydroxypropyl)trimethylammonium formate

Test material form:

liquid: viscous

Specific details on test material used for the study:

The sample was dosed as supplied.

Test animals

Species:

rabbit

Strain:

not specified

Remarks:

Albino Rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

N/A

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

All animals had their backs clipped free of hair 24 hours prior to testing . One half of the animals had their backs abraded prior to dosing.

All rabbits were weighed and the correct amount of experimental material was applied to the back of each animal. Treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
The dressings were removed after twenty-four hours. Excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities. Gross autopsies were performed
on a ll animals that died during the 14 day observation period.

Duration of exposure:

24 hours

Doses:

All animals were dosed at 2.0 g/kg (2000 mg/kg)

No. of animals per sex per dose:

5 male and 5 female animals in one dose group (2000 mg/kg)

Control animals:

no

Details on study design:

One group of ten albino rabbits (5 male and 5 female) weighing between 2.5 and 3.5 kg. each were employed in this study.
After the dosing period, the occlusion was removed and the animals were observed for a 14 day period for signs of toxicity and for mortalities. Gross autopsies would be performed on any animals that died during the 14 day observation period.

Statistics:

N/A

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortaities were observed

Clinical signs:

other: No unusual clinical or behavioral signs were noted.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, TMR-2 was found to have an acute dermal LD50 greater than 2.0 gm/kg ((2000 mg/kg)