Trometamol

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original report not available and documentation is insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

The physiological response of animals to some simple mononitroparaffins and to certain derivatives of these compounds

Author:

Machle, W. et al.

Year:

1940

Bibliographic source:

Journal of Industrial Hygiene and Toxicology, Oct. 1940; Vol. 22(3): 315-332

Materials and methods

Principles of method if other than guideline:

To estimate the dermal toxicity of the test substance, an amount was applied to the shaved skin of rabbits and left to dry without covering. The test site was washed after 4 hours. The animals were exposed daily for 5 consecutive days. The skin effects, clinical signs and body weight were monitored during the study period.

GLP compliance:

no

Remarks:

performed prior to GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trometamol

EC Number:

201-064-4

EC Name:

Trometamol

Cas Number:

77-86-1

Molecular formula:

C4H11NO3

IUPAC Name:

2-amino-2-(hydroxymethyl)propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): 2-amino-2-methylol-1,3-propanediol

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: Animals were housed individually

Administration / exposure

Type of coverage:

open

Vehicle:

not specified

Details on exposure:

TEST SITE
The fur of the animals was clipped closely to the skin of the anterior abdominal wall. The animals were secured and test substance was pipetted onto the clipped skin area. The test substance was left to dry, exposed to the air.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was washed with soap and water
- Time after start of exposure: 4 hours

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

4 hours, for 5 consecutive days

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

Doses / Concentrations:
The test substance was pipetted onto the skin in a 1/16th of an inch (0.16 cm) thick layer. The exact dose is not reported.
Basis:
no data

Control animals:

not specified

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes. Mortality and clinical signs.

DETAILED CLINICAL OBSERVATIONS: No

DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION: No

FOOD EFFICIENCY: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

OTHER: No

Sacrifice and pathology:

GROSS PATHOLOGY: No

HISTOPATHOLOGY: No

Results and discussion

Results of examinations

Details on results:

CLINICAL SIGNS AND MORTALITY
There was no mortality. No clinical signs were observed.

BODY WEIGHT AND WEIGHT GAIN
No body weight changes were noted.

OTHER FINDINGS
There were no local skin effects.

Target system / organ toxicity

Critical effects observed:

not specified